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Early diagnostic evaluation of patients with possible acute coronary syndrome, with special emphasis on troponin T Early diagnostic evaluation of patients with possible acute coronary syndrome, with special emphasis on troponin T Catharina Bornacenter349948500DOCTORAL DISSERTATIONby due permission of the Faculty of Medicine, Lund University, Sweden.To be defended at BMC Segerfalkssalen, Wallenberg Neurocentrum 2016-10-07 at 13:00Faculty opponentProfessor Hans Kirkegaard, MD, PhD?rhus UniversitetssjukhusOrganizationLund University, Faculty of Medicine, Department of Clinical Sciences at Lund, Emergency Medicine, Sweden.Document nameDOCTORAL DISSERTATIONDate of issue07-10-2016Author Catharina BornaSponsoring organizationTitle and subtitle: Early diagnostic evaluation of patients with possible acute coronary syndrome, with special emphasis on troponin TThe majority of chest pain patients presenting to the emergency department (ED) prove not to have acute coronary syndrome (ACS) and to identify patients without severe disease that may be discharged after minimal testing, is a challenge. Our first study was a retrospective real life study with the aim to validate the 2011 European Society of Cardiology (ESC) guidelines, which stated that non-ST-elevation acute coronary syndromes (NSTE-ACS) might be excluded with a rapid 3 h high-sensitivity troponin (hsTn) sampling protocol. We found that non ST-elevation myocardial infarction (NSTEMI), but not acute coronary syndrome (ACS), could be ruled out with hsTnT within 3-4 h from ED presentation (NPV 99% and 79%, respectively). We also found that using the standard cut-off (≤ 14 ng/L), hsTnT was unable to rule in ACS, and that hsTnT elevations were very common in patients ≥ 75 years presenting to the ED without ACS. These results were confirmed in paper III where we evaluated if higher cut offs for hsTnT, or a combination of a higher cut off and the early dynamic hsTnT change could improve specificity and PPV for ACS or NSTEMI in patients ≥ 75 years. The combination of a higher cut-off and the hsTnT change resulted in higher specificity and PPV but the diagnostic performance was not improved to an extent likely to be useful in routine clinical care. In paper II we evaluated if analyses of hsTnT and copeptin in combination could be used to rule out ACS immediately on patient presentation to the ED. We concluded that the combination could rule out NSTEMI at presentation, but not ACS. In the last paper, we found that a simple and fast diagnostic protocol (the CORE decision rule) could identify patients with a very low risk (< 1 %) for major adverse cardiac events (MACE) within 30 days from presentation. In conclusion, our studies have important implications for the current chest pain management in the ED. Key words: chest pain, acute coronary syndrome, high sensitivity troponin T, copeptinClassification system and/or index terms (if any)Supplementary bibliographical informationLanguage: EnglishISSN 1652-8220ISBN 978-91-7619-321-1Recipient’s notesNumber of pagesPriceSecurity classificationI, the undersigned, being the copyright owner of the abstract of the above-mentioned dissertation, hereby grant to all reference sourcespermission to publish and disseminate the abstract of the above-mentioned dissertation.Signature Date Early diagnostic evaluation of patients with possible acute coronary syndrome, with special emphasis on troponin T Catharina Bornacenter349948500Copyright ? Catharina BornaLund University, Faculty of Medicine, Department of Clinical Sciences at Lund, Emergency Medicine, Sweden.Lund University, Faculty of Medicine Doctoral Dissertation Series 2016:95ISBN 978-91-7619-321-1ISSN 1652-8220Printed in Sweden by Media-Tryck, Lund UniversityLund 2016 Always pass on what you have learnedTo my familyContent TOC \o "2-3" \t "Rubrik 1;1" Content PAGEREF _Toc453312136 \h 9List of publications PAGEREF _Toc453312137 \h 11Abbrevation list PAGEREF _Toc453312138 \h 12Abstract PAGEREF _Toc453312139 \h 13Background PAGEREF _Toc453312140 \h 15Ischemic heart disease PAGEREF _Toc453312141 \h 15Emergency Department Assessment of Acute-Onset Chest Pain PAGEREF _Toc453312142 \h 16Diagnostic tools to confirm or exclude acute coronary syndrome PAGEREF _Toc453312143 \h 16Troponin PAGEREF _Toc453312144 \h 18Copeptin PAGEREF _Toc453312145 \h 23Increasing diagnostic accuracy using decision supports PAGEREF _Toc453312146 \h 24Aims of the study PAGEREF _Toc453312147 \h 29Methods PAGEREF _Toc453312148 \h 31Study site PAGEREF _Toc453312149 \h 31Inclusion of patients PAGEREF _Toc453312150 \h 31Clinical assessment PAGEREF _Toc453312151 \h 31High-sensitivity troponin T assay PAGEREF _Toc453312152 \h 32Copeptin (Paper II) PAGEREF _Toc453312153 \h 32The Clinical Objective Rule-out Evaluation (CORE) (Paper IV) PAGEREF _Toc453312154 \h 33Recording of patient diagnosis and endpoints PAGEREF _Toc453312155 \h 34Follow-up PAGEREF _Toc453312156 \h 35Statistical analysis PAGEREF _Toc453312157 \h 35Results PAGEREF _Toc453312158 \h 37Diagnostic performance of hsTnT for ACS in real life PAGEREF _Toc453312159 \h 37Diagnostic performance for ACS in the elderly PAGEREF _Toc453312160 \h 39(Papers I and III) PAGEREF _Toc453312161 \h 39Diagnostic performance of high sensitivity troponin T and copeptin forearly rule-out of ACS PAGEREF _Toc453312162 \h 44The Clinical Objective Rule-out Evaluation (CORE) (Paper IV) PAGEREF _Toc453312163 \h 45Discussion PAGEREF _Toc453312164 \h 47A single hsTnT at 3-4 h can exclude NSTEMI in unselected ED patients PAGEREF _Toc453312165 \h 47Diagnostic accuracy for rule out of NSTEMI of hsTnT and copeptin at presentation is equivalent to hsTnT analysed at 3-4 h PAGEREF _Toc453312166 \h 48ACS cannot be excluded by biomarkers alone PAGEREF _Toc453312167 \h 48Diagnostic performance for hsTnT and copeptin as a rule in tool for ACS is poor. PAGEREF _Toc453312168 \h 49Low risk patients can be identified with the Clinical Objective Rule-out Evaluation (CORE) PAGEREF _Toc453312169 \h 50Conclusion and future directions PAGEREF _Toc453312170 \h 52Acknowledgement PAGEREF _Toc453312171 \h 54Popul?rvetenskaplig sammanfattning PAGEREF _Toc453312172 \h 56References PAGEREF _Toc453312173 \h 58List of publicationsThe thesis is based on the following papers, which will be referred to by their Roman numerals:Paper I: High-sensitivity troponin T as a diagnostic tool for acute coronary syndrome in the real world: an observational study.Catharina Borna, Johan Thelin, Bertil Ohlin, David Erlinge and Ulf Ekelund European Journal of Emergency Medicine 2014, 21:181–188Paper II:The combination of high sensitivity troponin T and copeptin facilitates early rule-out of ACS: a prospective observational study.Johan Thelin, Catharina Borna, David Erlinge and Bertil ?hlin.BMC Cardiovasc Disord. 2013; 13: 42.Paper III: Predictive role of high sensitivity troponin T within four hours from presentation?of acute coronary syndrome in?elderly patients. Catharina Borna, Katarina Lockman Frostred and Ulf Ekelund BMC Emergency Medicine (2016) 16:1 Paper IV: The clinical objective rule-out evaluation (CORE) allows early rule out of major adverse cardiac events in acute chest pain patients. Catharina Borna, Knut Kollberg, Arash Mokhtari, David Larsson and Ulf Ekelund. Submitted European Journal of Emergency Medicine. Abbrevation listACS = acute coronary syndromeAMI = acute myocardial infarction CABG = coronary artery bypass surgeryCI = confidence intervalCKD = chronic kidney disease ECG = electrocardiogram ED = Emergency DepartmentEDACS = Emergency Department Assessment of Chest pain Score HsTnT = high-sensitivity cardiac troponin T HsTn = high-sensitivity troponin LBBB = left bundle branch blockMACE = major adverse cardiac event MI = myocardial infarctionNPV = Negative predictive valueNSTE-ACS = non-ST-elevation acute coronary syndrome NSTEMI = non ST-elevation myocardial infarctionPCI = percutaneous coronary interventionSTEMI = ST-elevation myocardial infarctionSWEDEHEART = Swedish Web-system for Enhancement and Development of Evidence-based care in Heart Disease Evaluated According to Recommended TherapiesULN = upper limit of normal, 99th percentile of healthy controlsAbstractThe overall aim of this PhD project was to increase the understanding of the strengths and weaknesses of high-sensitivity cardiac troponin T (hsTnT) as an early diagnostic tool in patients with possible acute coronary syndrome. The majority of chest pain patients presenting to the emergency department (ED) prove not to have acute coronary syndrome (ACS). Distinguishing patients with ACS among the many patients with chest pain, and to identify patients without severe disease that may be discharged after minimal testing, is a challenge. Rapid and powerful diagnostic tools are needed in order to reduce inconvenience for the patient and costs for the health care system. In recent years, new high-sensitivity troponin (hsTn) tests have been presented, but their clinical value in routine care has not yet been established. In this thesis, chest pain patients presenting to the ED at the Sk?ne University Hospital in Lund were studied. Our first study was a retrospective real life study with the aim to validate the 2011 European Society of Cardiology (ESC) guidelines, which stated that non-ST-elevation acute coronary syndromes (NSTE-ACS) might be excluded with a rapid 3 h hsTn sampling protocol. We found that non ST-elevation myocardial infarction (NSTEMI), but not acute coronary syndrome (ACS), could be ruled out with hsTnT within 3-4 h from ED presentation in our unselected ED patients (NPV 99% and 79%, respectively). We also found that using the standard cut-off (≤ 14 ng/L), hsTnT was unable to rule in ACS, and that hsTnT elevations were very common in patients ≥ 75 years presenting to the ED without ACS. These results were confirmed in paper III where we evaluated if higher cut offs for hsTnT, or a combination of a higher cut off and the early dynamic hsTnT change could improve specificity and PPV for ACS or NSTEMI in patients ≥ 75 years. The combination of a higher cut-off and the hsTnT change resulted in higher specificity and PPV with maintained high sensitivity and NPV, but the diagnostic performance was not improved to an extent likely to be useful in routine clinical care.In paper II we evaluated if analyses of hsTnT and copeptin in combination could be used to rule out ACS immediately on patient presentation to the ED. We concluded that the combination could rule out NSTEMI at presentation, but not ACS. The combination of hsTnT and copeptin tests at presentation was equivalent to hsTnT analysed at 3-4 h. In the last paper, we found that a simple and fast diagnostic protocol (the CORE decision rule) could identify patients with a very low risk (< 1 %) for major adverse cardiac events (MACE) within 30 days from presentation. The first three real life studies in the present thesis are important complements to previous prospective studies performed in less generalisable settings. The findings support that hsTnT and copeptin are useful in the early rule-out of NSTEMI in both unselected and elderly ED patients. In contrast, a single value of hsTnT, or the combination of hsTnT and copeptin, cannot be used to rule in NSTEMI or ACS in unselected ED patients. In elderly patients, the limitations of hsTnT as a rule-in tool are even more pronounced.The CORE decision rule has the potential to shorten the length of ED stay and in particular, reduce the need of additional investigations and costs.In conclusion, our studies have led to a better understanding of hsTnT as an early diagnostic tool in patients with possible ACS. The results have important implications for the current chest pain management in the ED. BackgroundIschemic heart diseaseIt is well established that ischemic heart disease (IHD) is a leading cause of death in the western world. In Sweden cardiovascular disease was the underlying cause of death in 36 % of cases in 2014 (Swedeheart Annual Report 2015). IHD accounted for 44 % of cardiovascular causes. According to calculations from the Institute for Health Economics in Lund, the total economic cost in 2010 was SEK 61.5 billion including costs of medical care accounting, informal care by family and friends and loss of production. Several factors account for the increasing burden of cardiovascular disease, including longer average life span, tobacco use, decreased physical activity, and increased consumption of unhealthy food PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYWJlbDwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [1]. The term myocardial infarction (MI) signifies a loss of cardiac myocytes (necrosis) caused by prolonged ischemia. Acute coronary syndrome (ACS) refers to any group of clinical symptoms compatible with acute myocardial ischemia and includes unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) ADDIN EN.CITE <EndNote><Cite><Author>Kumar</Author><Year>2009</Year><RecNum>273</RecNum><DisplayText>[2]</DisplayText><record><rec-number>273</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">273</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kumar, A.</author><author>Cannon, C. P.</author></authors></contributors><auth-address>Department of Hospital Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA. amkrdoc@</auth-address><titles><title>Acute coronary syndromes: diagnosis and management, part I</title><secondary-title>Mayo Clin Proc</secondary-title><alt-title>Mayo Clinic proceedings</alt-title></titles><periodical><full-title>Mayo Clin Proc</full-title><abbr-1>Mayo Clinic proceedings</abbr-1></periodical><alt-periodical><full-title>Mayo Clin Proc</full-title><abbr-1>Mayo Clinic proceedings</abbr-1></alt-periodical><pages>917-38</pages><volume>84</volume><number>10</number><edition>2009/10/03</edition><keywords><keyword>Acute Coronary Syndrome/*diagnosis/etiology/*therapy</keyword><keyword>Angina, Unstable/etiology/pathology/physiopathology</keyword><keyword>Biological Markers/metabolism</keyword><keyword>Coronary Artery Disease/complications/pathology/therapy</keyword><keyword>Critical Pathways</keyword><keyword>Emergency Service, Hospital/organization & administration</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/*diagnosis/etiology/*therapy</keyword><keyword>Risk Assessment</keyword></keywords><dates><year>2009</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1942-5546 (Electronic)
0025-6196 (Linking)</isbn><accession-num>19797781</accession-num><work-type>Review</work-type><urls><related-urls><url>(11)60509-0</electronic-resource-num><language>eng</language></record></Cite></EndNote>[2]. NSTE-ACS is three times more common than STEMI and account for about 1 million hospital admissions yearly in the United States PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYWJlbDwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [1].Universal definition of myocardial infarction PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]A combination of criteria is required to warrant the diagnosis of AMI; a dynamic change of a biomarker of myocardial necrosis, and at least one of the following:Symptoms of ischemiaNew ST-T wave changes on ECGDevelopment of Q waves on ECGImaging evidence of new loss of viable myocardiumIntracoronary thrombusDistinguishing type 1 MI from type 2 MIType 1 MI occurs after an atherosclerotic plaque rupture resulting in decreased myocardial blood flow. Type 2 MI is a myocardial necrosis due to an imbalance between myocardial oxygen supply and demand. This can be seen in conditions like arrhythmias, heart failure, anemia and respiratory failure PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaHlnZXNlbjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA [4]. It can sometimes be difficult for clinicians to distinguish these two types of MI, and there is a need for clarification in this area to define the frequency and prognosis of type 2 MI. It is also important that appropriate therapy can be administered to the patients with type 1 MI ADDIN EN.CITE <EndNote><Cite><Author>Alpert</Author><Year>2014</Year><RecNum>1</RecNum><DisplayText>[5]</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="tsrar5e0cv292jed0wavset2aev20v59w9x0">1</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Alpert, J. S.</author><author>Thygesen, K. A.</author><author>White, H. D.</author><author>Jaffe, A. S.</author></authors></contributors><auth-address>Sarver Heart Center, University of Arizona College of Medicine, Tucson. Electronic address: jalpert@shc.arizona.edu.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
Mayo Clinic, Rochester, Minn.</auth-address><titles><title>Diagnostic and therapeutic implications of type 2 myocardial infarction: review and commentary</title><secondary-title>Am J Med</secondary-title><alt-title>The American journal of medicine</alt-title></titles><pages>105-8</pages><volume>127</volume><number>2</number><edition>2014/01/28</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Blood Pressure</keyword><keyword>*Coronary Circulation</keyword><keyword>Electrocardiography</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/blood/*diagnosis/metabolism/physiopathology/*therapy</keyword><keyword>Myocardium/*metabolism/*pathology</keyword><keyword>Necrosis</keyword><keyword>*Oxygen Consumption</keyword><keyword>Troponin/blood</keyword></keywords><dates><year>2014</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1555-7162 (Electronic)
0002-9343 (Linking)</isbn><accession-num>24462011</accession-num><work-type>Review</work-type><urls><related-urls><url>(13)00880-2/pdf</url></related-urls></urls><electronic-resource-num>10.1016/j.amjmed.2013.09.031</electronic-resource-num><language>eng</language></record></Cite></EndNote>[5].Emergency Department Assessment of Acute-Onset Chest PainChest pain is a frequent symptom in the ED but the majority of these patients prove not to have ACS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Fa2VsdW5kPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48
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ADDIN EN.CITE.DATA [8], i.e. AMI or UA. One challenge in the ED is to safely identify cases without severe disease. A fast and efficient way to identify patients eligible for early discharge is needed to avoid prolonged stays, investigations and unnecessary admissions. It has been estimated that about 6000 SEK (approx. 640 €) could be saved for each patient if patients without ACS could be discharged directly from the ED instead of being admitted ADDIN EN.CITE <EndNote><Cite><Author>Forberg</Author><Year>2006</Year><RecNum>29</RecNum><DisplayText>[9]</DisplayText><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">29</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Forberg, J. L.</author><author>Henriksen, L. S.</author><author>Edenbrandt, L.</author><author>Ekelund, U.</author></authors></contributors><auth-address>Department of Emergency Medicine, Lund University Hospital, Lund, Sweden. jakob@</auth-address><titles><title>Direct hospital costs of chest pain patients attending the emergency department: a retrospective study</title><secondary-title>BMC Emerg Med</secondary-title><alt-title>BMC emergency medicine</alt-title></titles><periodical><full-title>BMC Emerg Med</full-title><abbr-1>BMC emergency medicine</abbr-1></periodical><alt-periodical><full-title>BMC Emerg Med</full-title><abbr-1>BMC emergency medicine</abbr-1></alt-periodical><pages>6</pages><volume>6</volume><edition>2006/05/06</edition><dates><year>2006</year></dates><isbn>1471-227X (Electronic)
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ADDIN EN.CITE.DATA [3].Symptom history and clinical presentationPatients with ACS may present with various symptoms but the most common one is chest pain PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]. The patients included in this thesis are strictly patients presenting with chest pain and the results can only be applied to this group of patients. The typical chest pain in ACS is characterized as a retrosternal pressure that sometimes radiate to the left or right arm and that may be intermittent. Atypical symptoms like epigastric pain, dyspnoea or nausea can and often do occur PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]. Overall the diagnostic value of chest pain characteristics is limited ADDIN EN.CITE <EndNote><Cite><Author>Panju</Author><Year>1998</Year><RecNum>675</RecNum><DisplayText>[10]</DisplayText><record><rec-number>675</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">675</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Panju, A. A.</author><author>Hemmelgarn, B. R.</author><author>Guyatt, G. H.</author><author>Simel, D. L.</author></authors></contributors><auth-address>Department of Medicine, McMaster University, Hamilton, Ontario, Canada. panjuaa@fhs.csu.mcmaster.ca</auth-address><titles><title>The rational clinical examination. Is this patient having a myocardial infarction?</title><secondary-title>JAMA</secondary-title><alt-title>Jama</alt-title></titles><periodical><full-title>JAMA</full-title><abbr-1>JAMA : the journal of the American Medical Association</abbr-1></periodical><alt-periodical><full-title>JAMA</full-title><abbr-1>JAMA : the journal of the American Medical Association</abbr-1></alt-periodical><pages>1256-63</pages><volume>280</volume><number>14</number><edition>1998/10/24</edition><keywords><keyword>Acute Disease</keyword><keyword>Algorithms</keyword><keyword>Chest Pain</keyword><keyword>Decision Support Techniques</keyword><keyword>Electrocardiography</keyword><keyword>Heart Sounds</keyword><keyword>Humans</keyword><keyword>Hypotension</keyword><keyword>Medical History Taking</keyword><keyword>Myocardial Infarction/*diagnosis</keyword><keyword>Physical Examination</keyword><keyword>Probability</keyword></keywords><dates><year>1998</year><pub-dates><date>Oct 14</date></pub-dates></dates><isbn>0098-7484 (Print)
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ADDIN EN.CITE.DATA [3, 12]. Dementia is more common in this group making the assessment even more difficult.ECGOn the ECG, myocardial ischemia with a risk of AMI can be manifested either as ST segment elevation, ST depression or T-wave inversion. In ED chest pain patients, it is recommended to obtain a 12-lead ECG within 10 min after presentation to exclude persistent ST-segment elevation. Patients with ST-segment elevation in general have a large AMI (STEMI) and need urgent reperfusion therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [13, 14]. In contrast, isolated T-wave inversion, has not been associated with worse prognosis. The initial 12-lead ECG in ED patients with suspected ACS is diagnostic of injury in only 24% to 60% of patients with a final diagnosis of AMI, indicating that ECG has a limited value for diagnosing ACS without ST elevation (NSTE-ACS) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CbG9ta2FsbnM8L0F1dGhvcj48WWVhcj4yMDAzPC9ZZWFy
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ADDIN EN.CITE.DATA [15]. Nor is the ECG very useful for diagnosing NSTE-ACS in patients with paced rhythm or LBBB PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]. Interpretation of the ECG mainly relies on direct visual assessment and previous studies have suggested that misinterpretation of the ECG in the ED is relatively common, but the implications of this are still under debate PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXNvdWRpPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48
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ADDIN EN.CITE.DATA [16-18].Diagnostic BiomarkersA good biomarker should be easily measured and promptly provide meaningful results. The figure shows a variety of biomarkers in AMI and their relationship to various pathophysiological processes.Figure 1Biomarkers associated with various pathophysiological processes associated with acute myocardial infarction. (Chan and Ng BMC Medicine 2010, 8:34 )Two well-known biomarkers in use for diagnosis of AMI are Creatine-Kinase-MB isoform (CKMB) and cardiac Troponin. In 2000, cardiac Troponin replaced CK-MB as the biomarker of choice for diagnosing a myocardial infarction in the western world ADDIN EN.CITE <EndNote><Cite><Author>Chan</Author><Year>2010</Year><RecNum>275</RecNum><DisplayText>[19]</DisplayText><record><rec-number>275</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">275</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chan, D.</author><author>Ng, L. L.</author></authors></contributors><auth-address>Leicester National Institute for Health Research Cardiovascular Biomedical Research Unit, UK.</auth-address><titles><title>Biomarkers in acute myocardial infarction</title><secondary-title>BMC Med</secondary-title><alt-title>BMC medicine</alt-title></titles><periodical><full-title>BMC Med</full-title><abbr-1>BMC medicine</abbr-1></periodical><alt-periodical><full-title>BMC Med</full-title><abbr-1>BMC medicine</abbr-1></alt-periodical><pages>34</pages><volume>8</volume><edition>2010/06/10</edition><keywords><keyword>Biological Markers/*blood</keyword><keyword>Blood Chemical Analysis</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/*diagnosis</keyword><keyword>Prognosis</keyword></keywords><dates><year>2010</year></dates><isbn>1741-7015 (Electronic)
1741-7015 (Linking)</isbn><accession-num>20529285</accession-num><work-type>Research Support, Non-U.S. Gov't
Review</work-type><urls><related-urls><url>*~hmac=d812a165cd52d47b260ba6fefb3189c81a04b43cea84e8a2a5b75e11d957f1d3</url></related-urls></urls><custom2>2898678</custom2><electronic-resource-num>10.1186/1741-7015-8-34</electronic-resource-num><language>eng</language></record></Cite></EndNote>[19]. TroponinCardiac troponins (cTn) are proteins bound to the actin components of the myofibrils of cardiac muscle, and different isoforms (cTnI and cTnT) exist with unique N-terminal sequences that distinguish them from the skeletal muscle isoforms. Figure 2Structure of the core complex of troponin (Copyright ? 2016 National Academy of Sciences)Cardiac troponin is highly specific to cardiac tissue and is released from myocytes into the blood stream when irreversible myocardial infarction occurs. However, there are forms of skeletal muscle disease that could increase circulating levels of cTnT in the absence of cardiovascular disease. This phenomenon has not been described with cTnI PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KYWZmZTwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [19, 21]. Figure 3Release of cardiac troponin in acute myocardial : a diagram of a cardiomyocyte releasing biomarkers. Most troponins exists as a complex of C, I and T components that are bound to actin filament. Small amounts of troponins are free in the cytoplasm. Bottom: the pattern of release of different biomarkers based on time after an acute myocardial infarction (AMI) including myoglobin, creatine kinase myocardial band (CKMB), lactate dehydrogenase (LD) and cardiac troponin I (cTnI) and T (cTnT). (Archan et al, Anesthesiology?4 2010, Vol.112, 1005-1012. With permission from Dr Lee A Fleisher)Since the introduction of blood troponin analysis in the early 1990s, there have been questions about the clinical significance of an elevated troponin. After many years of skepticism, troponins were accepted as the gold standard for patients with chest pain by classifying them into troponin-positive and troponin-negative patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYW1tPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [30].The recently introduced hsTn assays have improved the accuracy at the lower limit of detection and provide important diagnostic information in the early phase of myocardial infarction PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [31, 32]. These assays measure the upper limit of normal (ULN), the 99th percentile of healthy controls, with a coefficient of variation (CV) of 10%, and permit measurement of cTn concentrations in > 50 % of healthy individuals ADDIN EN.CITE <EndNote><Cite><Author>Maznyczka</Author><Year>2015</Year><RecNum>679</RecNum><DisplayText>[33]</DisplayText><record><rec-number>679</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">679</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Maznyczka, A.</author><author>Kaier, T.</author><author>Marber, M.</author></authors></contributors><auth-address>King's College London, British Heart Foundation Centre of Research Excellence, London, UK.
Department of Cardiology, Royal Free Hospital, London, UK.</auth-address><titles><title>Troponins and other biomarkers in the early diagnosis of acute myocardial infarction</title><secondary-title>Postgrad Med J</secondary-title><alt-title>Postgraduate medical journal</alt-title></titles><periodical><full-title>Postgrad Med J</full-title><abbr-1>Postgraduate medical journal</abbr-1></periodical><alt-periodical><full-title>Postgrad Med J</full-title><abbr-1>Postgraduate medical journal</abbr-1></alt-periodical><pages>322-30</pages><volume>91</volume><number>1076</number><edition>2015/05/24</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Chest Pain/blood/*etiology</keyword><keyword>Early Diagnosis</keyword><keyword>Emergency Service, Hospital</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/blood/*diagnosis</keyword><keyword>Practice Guidelines as Topic</keyword><keyword>Prognosis</keyword><keyword>Time Factors</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2015</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1469-0756 (Electronic)
0032-5473 (Linking)</isbn><accession-num>26002926</accession-num><work-type>Review</work-type><urls><related-urls><url>;[33]. The use of more specific antibodies, increased sample volume and an optmimised buffert solution have enabled the analytic improvement. The use of hsTnT assays has resulted in fewer people being classified as having unstable angina (UA) and more people classified as having NSTEMI PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hb29kYWNyZTwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+
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ADDIN EN.CITE.DATA [28, 31, 32, 36]. In Paper I, we aimed to evaluate the diagnostic and prognostic performance of hsTnT in a real-world setting, i.e. in unselected chest pain patients admitted with possible ACS in routine care.Increased analytic sensitivity of troponin assays not only increases detection of AMI, but also of the many other conditions with elevated troponin levels such as pulmonary embolism, heart failure, tachycardia and renal failure PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2V3YWxsPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA [42]. However, in this study, adjucation of the diagnosis was based on a conventional TnI assay increasing the risk for systematic bias favoring the hsTnI assay. The daily clinical challenge in using the highly sensitive assays is to interpret the troponin concentrations in patients with concomitant disease. A simple classifying into troponin-positive and troponin-negative patients is no longer an option. Instead we now evaluate hsTn kinetics with serial testing in the clinical evaluation of chest pain patients. However, dynamic changes are not specific for ACS, and other acute conditions leading to myocardial necrosis will also be associated with changes of hsTn ADDIN EN.CITE <EndNote><Cite><Author>Jneid</Author><Year>2013</Year><RecNum>435</RecNum><DisplayText>[43]</DisplayText><record><rec-number>435</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">435</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jneid, H.</author><author>Alam, M.</author><author>Virani, S. S.</author><author>Bozkurt, B.</author></authors></contributors><auth-address>Baylor College of Medicine, Houston, Texas ; Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.</auth-address><titles><title>Redefining myocardial infarction: what is new in the ESC/ACCF/AHA/WHF Third Universal Definition of myocardial infarction?</title><secondary-title>Methodist Debakey Cardiovasc J</secondary-title><alt-title>Methodist DeBakey cardiovascular journal</alt-title></titles><periodical><full-title>Methodist Debakey Cardiovasc J</full-title><abbr-1>Methodist DeBakey cardiovascular journal</abbr-1></periodical><alt-periodical><full-title>Methodist Debakey Cardiovasc J</full-title><abbr-1>Methodist DeBakey cardiovascular journal</abbr-1></alt-periodical><pages>169-72</pages><volume>9</volume><number>3</number><edition>2013/09/26</edition><keywords><keyword>Biomarkers/*blood</keyword><keyword>*Consensus</keyword><keyword>*Electrocardiography</keyword><keyword>Humans</keyword><keyword>*Myocardial Infarction/blood/classification/diagnosis</keyword><keyword>*Societies, Medical</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul-Sep</date></pub-dates></dates><isbn>1947-6108 (Electronic)
1947-6108 (Linking)</isbn><accession-num>24066201</accession-num><work-type>Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review</work-type><urls><related-urls><url>;[43]. The changes of hsTn over time will be determined by the underlying acute cardiac event as well as analytical and biological variation. It is therefore important to establish the reference change values (RCVs) for each biomarker and assay PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GcmFua2Vuc3RlaW48L0F1dGhvcj48WWVhcj4yMDExPC9Z
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ADDIN EN.CITE.DATA [3] it is proposed that elevations beyond 5-fold the ULN have a high positive predictive value for AMI type 1, but the guidelines fail to provide a reference for this statement. This is an area where current guidelines are not sufficient.Troponin and renal insufficiencyCardiovascular disease is the most common cause of death in patients with renal insufficiency. Cardiac troponins can be elevated in some patients with renal failure but the interpretation of an elevated troponin is controversial. Most of the large-scale trials of patients with ACS exclude patients with elevated serum creatinine ADDIN EN.CITE <EndNote><Cite><Author>Freda</Author><Year>2002</Year><RecNum>387</RecNum><DisplayText>[48]</DisplayText><record><rec-number>387</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">387</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Freda, B. J.</author><author>Tang, W. H.</author><author>Van Lente, F.</author><author>Peacock, W. F.</author><author>Francis, G. S.</author></authors></contributors><auth-address>Department of Internal Medicine, Cleveland Clinic Foundation, Ohio 44195, USA.</auth-address><titles><title>Cardiac troponins in renal insufficiency: review and clinical implications</title><secondary-title>J Am Coll Cardiol</secondary-title><alt-title>Journal of the American College of Cardiology</alt-title></titles><periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></periodical><alt-periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></alt-periodical><pages>2065-71</pages><volume>40</volume><number>12</number><edition>2002/12/31</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Creatine Kinase/blood</keyword><keyword>Humans</keyword><keyword>Kidney Failure, Chronic/*blood/complications</keyword><keyword>Myocardial Ischemia/*blood/complications/diagnosis</keyword><keyword>Renal Dialysis</keyword><keyword>Risk Factors</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2002</year><pub-dates><date>Dec 18</date></pub-dates></dates><isbn>0735-1097 (Print)
0735-1097 (Linking)</isbn><accession-num>12505215</accession-num><work-type>Review</work-type><urls><related-urls><url>;[48]. The underlying mechanisms of elevated troponin in patients with renal insufficiency are not completely understood. On-going subclinical micro-infarctions and myocardial hypertrophy have been suggested as causes. Decreased clearance by the failing kidney has also been proposed but this is less likely since the free cTnT is a relatively large molecule (37 kDa) similar to albumin making it improbable that troponin is cleared by the kidney. Furthermore, the majority of studies have failed to show a relationship between serum creatinine levels and the degree of troponin elevation ADDIN EN.CITE <EndNote><Cite><Author>Freda</Author><Year>2002</Year><RecNum>387</RecNum><DisplayText>[48]</DisplayText><record><rec-number>387</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">387</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Freda, B. J.</author><author>Tang, W. H.</author><author>Van Lente, F.</author><author>Peacock, W. F.</author><author>Francis, G. S.</author></authors></contributors><auth-address>Department of Internal Medicine, Cleveland Clinic Foundation, Ohio 44195, USA.</auth-address><titles><title>Cardiac troponins in renal insufficiency: review and clinical implications</title><secondary-title>J Am Coll Cardiol</secondary-title><alt-title>Journal of the American College of Cardiology</alt-title></titles><periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></periodical><alt-periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></alt-periodical><pages>2065-71</pages><volume>40</volume><number>12</number><edition>2002/12/31</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Creatine Kinase/blood</keyword><keyword>Humans</keyword><keyword>Kidney Failure, Chronic/*blood/complications</keyword><keyword>Myocardial Ischemia/*blood/complications/diagnosis</keyword><keyword>Renal Dialysis</keyword><keyword>Risk Factors</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2002</year><pub-dates><date>Dec 18</date></pub-dates></dates><isbn>0735-1097 (Print)
0735-1097 (Linking)</isbn><accession-num>12505215</accession-num><work-type>Review</work-type><urls><related-urls><url>;[48].Patients with chronic kidney disease (CKD) are thus more likely than those without it to have elevated troponin levels. Studies of patients with CKD have shown that chronically elevated troponin levels are associated with increased risk for cardiovascular morbidity and mortality. Whether asymptomatic patients with CKD and elevated troponin levels should be treated differently from those with normal levels is unclear ADDIN EN.CITE <EndNote><Cite><Author>Freda</Author><Year>2002</Year><RecNum>387</RecNum><DisplayText>[48]</DisplayText><record><rec-number>387</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">387</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Freda, B. J.</author><author>Tang, W. H.</author><author>Van Lente, F.</author><author>Peacock, W. F.</author><author>Francis, G. S.</author></authors></contributors><auth-address>Department of Internal Medicine, Cleveland Clinic Foundation, Ohio 44195, USA.</auth-address><titles><title>Cardiac troponins in renal insufficiency: review and clinical implications</title><secondary-title>J Am Coll Cardiol</secondary-title><alt-title>Journal of the American College of Cardiology</alt-title></titles><periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></periodical><alt-periodical><full-title>J Am Coll Cardiol</full-title><abbr-1>Journal of the American College of Cardiology</abbr-1></alt-periodical><pages>2065-71</pages><volume>40</volume><number>12</number><edition>2002/12/31</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Creatine Kinase/blood</keyword><keyword>Humans</keyword><keyword>Kidney Failure, Chronic/*blood/complications</keyword><keyword>Myocardial Ischemia/*blood/complications/diagnosis</keyword><keyword>Renal Dialysis</keyword><keyword>Risk Factors</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2002</year><pub-dates><date>Dec 18</date></pub-dates></dates><isbn>0735-1097 (Print)
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ADDIN EN.CITE.DATA [49]. Specificity and PPV for AMI have been described to be very low, 12 and 3 % respectively ADDIN EN.CITE <EndNote><Cite><Author>Wang</Author><Year>2012</Year><RecNum>683</RecNum><DisplayText>[50]</DisplayText><record><rec-number>683</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">683</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wang, A. Y.</author><author>Wai-Kei Lam, C.</author></authors></contributors><auth-address>Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong. aymwang@hku.hk</auth-address><titles><title>The diagnostic utility of cardiac biomarkers in dialysis patients</title><secondary-title>Semin Dial</secondary-title><alt-title>Seminars in dialysis</alt-title></titles><periodical><full-title>Semin Dial</full-title><abbr-1>Seminars in dialysis</abbr-1></periodical><alt-periodical><full-title>Semin Dial</full-title><abbr-1>Seminars in dialysis</abbr-1></alt-periodical><pages>388-96</pages><volume>25</volume><number>4</number><edition>2012/07/04</edition><keywords><keyword>Biomarkers/blood</keyword><keyword>Cardiovascular Diseases/*blood/complications/*diagnosis</keyword><keyword>Humans</keyword><keyword>Kidney Failure, Chronic/*complications</keyword><keyword>Natriuretic Peptide, Brain/blood</keyword><keyword>Peptide Fragments/blood</keyword><keyword>Prognosis</keyword><keyword>*Renal Dialysis</keyword><keyword>Troponin/blood</keyword></keywords><dates><year>2012</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1525-139X (Electronic)
0894-0959 (Linking)</isbn><accession-num>22748194</accession-num><work-type>Research Support, Non-U.S. Gov't
Review</work-type><urls><related-urls><url>;[50]. Troponin and ageThe prevalence of symptomatic ischemic heart disease increases with age. In the United States, elderly patients represent the majority of cardiovascular patients and about 21% of men and 11% of women aged 60–79 years had ischemic heart disease in 2012 ADDIN EN.CITE <EndNote><Cite><Author>Rains</Author><Year>2014</Year><RecNum>233</RecNum><DisplayText>[51]</DisplayText><record><rec-number>233</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">233</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rains, M. G.</author><author>Laney, C. A.</author><author>Bailey, A. L.</author><author>Campbell, C. L.</author></authors></contributors><auth-address>Gill Heart Institute, Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.
Gill Heart Institute, Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA ; Lexington Veterans Administration Hospital, Lexington, KY, USA.</auth-address><titles><title>Biomarkers of acute myocardial infarction in the elderly: troponin and beyond</title><secondary-title>Clin Interv Aging</secondary-title><alt-title>Clinical interventions in aging</alt-title></titles><periodical><full-title>Clin Interv Aging</full-title><abbr-1>Clinical interventions in aging</abbr-1></periodical><alt-periodical><full-title>Clin Interv Aging</full-title><abbr-1>Clinical interventions in aging</abbr-1></alt-periodical><pages>1081-90</pages><volume>9</volume><edition>2014/07/24</edition><keywords><keyword>Aged</keyword><keyword>Aging/*blood</keyword><keyword>Biological Markers/blood</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/*blood/*diagnosis</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2014</year></dates><isbn>1178-1998 (Electronic)
1176-9092 (Linking)</isbn><accession-num>25053882</accession-num><work-type>Review</work-type><urls><related-urls><url>;[51].The ULN of hsTnT has been determined by analysis on apparently healthy subjects PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWVuZ2VyPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA [53-57]. Previous studies have shown that false-positive results for hsTnT are very common, especially in the elderly where conditions like pulmonary embolism, heart failure, tachycardia and renal failure are more frequent PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PbGl2aWVyaTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA [52]. In a study from 2012 where all high-sensitivity cardiac troponin assays were tested, ULN for males were 1.2 to 2.4 times higher than those for females PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcHBsZTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ZE5vdGU+
ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcHBsZTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ZE5vdGU+
ADDIN EN.CITE.DATA [61]. In a study including 13 000 patients the 99th percentile for hsTnT in men > 65 years was 31ng/l PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hb3JlPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [63]. At this time, there is insufficient data to recommend gender-specific cut-offs.Rule-in and rule-outSeveral studies have tried to develop a three-zone strategy; rule-in, observational and rule-out based on either a 1 h or 3 h protocol after patient presentation together with clinical data and ECG findings PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA [3, 66-68]. With these strategies, the overall NPV for MI in the rule-out group has been >98%, but in the rule-in group up to 25% of the patients will not have AMI, indicating that hsTnT has substantial limitations as a rule-in tool PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]. Even if the three-zone strategy is theoretically appealing, there will be substantial difficulties in actually implementing this rather complicated strategy. CopeptinCardiac troponins are released after myocardial cell disintegration and are markers of cell necrosis. This may be the reason for the relative weakness in diagnostic performance in patients presenting early after chest pain onset. Many additional biomarkers have been suggested to be useful in the diagnosis of ACS, but very few have been shown to be clinically useful ADDIN EN.CITE <EndNote><Cite><Author>Chan</Author><Year>2010</Year><RecNum>275</RecNum><DisplayText>[19]</DisplayText><record><rec-number>275</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">275</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chan, D.</author><author>Ng, L. L.</author></authors></contributors><auth-address>Leicester National Institute for Health Research Cardiovascular Biomedical Research Unit, UK.</auth-address><titles><title>Biomarkers in acute myocardial infarction</title><secondary-title>BMC Med</secondary-title><alt-title>BMC medicine</alt-title></titles><periodical><full-title>BMC Med</full-title><abbr-1>BMC medicine</abbr-1></periodical><alt-periodical><full-title>BMC Med</full-title><abbr-1>BMC medicine</abbr-1></alt-periodical><pages>34</pages><volume>8</volume><edition>2010/06/10</edition><keywords><keyword>Biological Markers/*blood</keyword><keyword>Blood Chemical Analysis</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/*diagnosis</keyword><keyword>Prognosis</keyword></keywords><dates><year>2010</year></dates><isbn>1741-7015 (Electronic)
1741-7015 (Linking)</isbn><accession-num>20529285</accession-num><work-type>Research Support, Non-U.S. Gov't
Review</work-type><urls><related-urls><url>*~hmac=d812a165cd52d47b260ba6fefb3189c81a04b43cea84e8a2a5b75e11d957f1d3</url></related-urls></urls><custom2>2898678</custom2><electronic-resource-num>10.1186/1741-7015-8-34</electronic-resource-num><language>eng</language></record></Cite></EndNote>[19]. Among the many tested, copeptin is one of few additional biomarker that seems to have clinical relevance PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2ZmaTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3]. Figure 4Synthesis and release of AVP and copeptin in hypothalamus and pituitary. Pro-AVP is processed in the hypothalamus, followed by two distinct release-mechanisms for the anterior and posterior pituitary. During stress, a drop in blood pressure, or a change in osmotic pressure, AVP is released into the circulation. ACTH: adrenocorticotropic hormone; AVP: arginine vasopressin. (? Nickel et al; licensee BioMed Central Ltd.2012)The antidiuretic hormone arginin-vasopressin is secreted by the neurohypophysis and controls osmotic hemostasis. Copeptin is the c-terminal of the vasopressin precursor hormone and is co-secreted with the hormone PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JnZW50aGFsZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9Z
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ADDIN EN.CITE.DATA [69]. Copeptin blood levels therefore directly reflect vasopressin release but have a longer half-life than vasopressin, which makes it easier to detect and analyse. Vasopressin, and thereby copeptin, is released by endogenous stress and increase immediately after chest pain onset PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JnZW50aGFsZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9Z
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JnZW50aGFsZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9Z
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ADDIN EN.CITE.DATA [71, 72]. Some publications address the potential benefit of the combination of troponins and copeptin to safely rule out ACS already at presentation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA [72, 73, 75, 76]. In Paper II we evaluate the combination of hsTnT and copeptin in an early rule-out strategy for ACS. Figure 5Temporal release pattern of copeptin versus CK-MB, cTnT, and hs-cTnT. The?dashed horizontal line?represents the upper limit of normal (99th percentile) for copeptin. (Yolan et al; Clin Res Cardiol. 2011 Dec; 100(12): 1069–1076)Increasing diagnostic accuracy using decision supportsDecision support tools are meant to add more objectively estimated probabilities to the common practice in order to predict the risk of serious outcome events ADDIN EN.CITE <EndNote><Cite><Author>Moons</Author><Year>2012</Year><RecNum>636</RecNum><DisplayText>[77]</DisplayText><record><rec-number>636</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">636</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Moons, K. G.</author><author>Kengne, A. P.</author><author>Woodward, M.</author><author>Royston, P.</author><author>Vergouwe, Y.</author><author>Altman, D. G.</author><author>Grobbee, D. E.</author></authors></contributors><auth-address>Julius Center for Health Sciences and Primary Care, UMC Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. k.g.m.moons@umcutrecht.nl</auth-address><titles><title>Risk prediction models: I. Development, internal validation, and assessing the incremental value of a new (bio)marker</title><secondary-title>Heart</secondary-title></titles><periodical><full-title>Heart</full-title></periodical><pages>683-90</pages><volume>98</volume><number>9</number><edition>2012/03/09</edition><keywords><keyword>Biomarkers/*analysis</keyword><keyword>Cardiovascular Diseases/*diagnosis/metabolism</keyword><keyword>Cost-Benefit Analysis</keyword><keyword>*Decision Making</keyword><keyword>*Decision Support Techniques</keyword><keyword>Humans</keyword><keyword>*Models, Theoretical</keyword><keyword>Predictive Value of Tests</keyword><keyword>Reproducibility of Results</keyword><keyword>Risk</keyword></keywords><dates><year>2012</year><pub-dates><date>May</date></pub-dates></dates><isbn>1468-201X (Electronic)
1355-6037 (Linking)</isbn><accession-num>22397945</accession-num><work-type>Research Support, Non-U.S. Gov't
Review</work-type><urls><related-urls><url>;[77]. When designing a decision support for the ED it is critical to understand clinicians’ working conditions. Most of the time, working pace is high with frequent interruptions due to the demands of constant availability. Speed and usability are therefore of paramount importance when decision supports are to be integrated with practice. A decision support that delivers several alternatives is seldom useful; simple directions are preferable PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYXRlczwvQXV0aG9yPjxZZWFyPjIwMDM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [78].To be adopted by professionals the decision support must improve patient outcomes and the cost effectiveness of care. Validation studies are important because the performance is often not as good as in the original studies when applied to new individuals ADDIN EN.CITE <EndNote><Cite><Author>Moons</Author><Year>2012</Year><RecNum>635</RecNum><DisplayText>[79]</DisplayText><record><rec-number>635</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">635</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Moons, K. G.</author><author>Kengne, A. P.</author><author>Grobbee, D. E.</author><author>Royston, P.</author><author>Vergouwe, Y.</author><author>Altman, D. G.</author><author>Woodward, M.</author></authors></contributors><auth-address>Julius Centre for Health Sciences and Primary Care, UMC Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. k.g.m.moons@umcutrecht.nl</auth-address><titles><title>Risk prediction models: II. External validation, model updating, and impact assessment</title><secondary-title>Heart</secondary-title></titles><periodical><full-title>Heart</full-title></periodical><pages>691-8</pages><volume>98</volume><number>9</number><edition>2012/03/09</edition><keywords><keyword>*Cardiovascular Diseases/diagnosis/epidemiology/therapy</keyword><keyword>*Decision Making</keyword><keyword>Delivery of Health Care/*organization & administration</keyword><keyword>Humans</keyword><keyword>*Models, Theoretical</keyword><keyword>Prognosis</keyword><keyword>Reproducibility of Results</keyword><keyword>Risk Assessment/*methods</keyword></keywords><dates><year>2012</year><pub-dates><date>May</date></pub-dates></dates><isbn>1468-201X (Electronic)
1355-6037 (Linking)</isbn><accession-num>22397946</accession-num><work-type>Research Support, Non-U.S. Gov't
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AG==
ADDIN EN.CITE.DATA [87] has shown great potential (sensitivity 100%, specificity 50-59%) but is like the HEART-score hard to use without electronic assistance, which is a great limitation and makes them both less likely to be accepted by clinicians. According to current European guidelines, simple risk scores like TIMI are preferred due to its few variables, its additive scoring system and a binary outcome. GRACEVariables used in the GRACE 2.0 risk calculation include age, systolic blood pressure, pulse rate, serum creatinine, Killip class at presentation, cardiac arrest at admission, elevated cardiac biomarkers and ST deviation on the ECG. The score is highly driven by age and were originally designed for patients with established ACS and not for unselected ED chest pain patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmFuZ2VyPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48
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ADDIN EN.CITE.DATA [89].TIMIThe TIMI risk score uses seven variables in an additive system: age ≥65 years, three or more coronary artery disease (CAD) risk factors, known CAD, aspirin use in the past 7 days, severe angina (two or more episodes within 24 h), ST change ≥0.5 mm and a positive cardiac blood marker. As with the GRACE score, TIMI risk score was originally designed for risk assessment in patients with established ACS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbnRtYW48L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [3]. Disadvantages with the TIMI risk score include the highly subjective variable of “≥ 2 episodes of severe angina within the last 24 h”, and also the variable “aspirin use within 7 days” which many clinicians find counterintuitive. In a metaanalysis from 2010 including 17 000 patients it was stated that TIMI was insufficiently sensitive to identify ED patients for early discharge. Conventional biomarkers were used in these studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXNzPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [90].HEARTHEART is a risk score with five variables; patient history, ECG abnormalities, risk factors, age and elevated troponin. It is complicated, hard to use without electronic assistance and include subjective variables ADDIN EN.CITE <EndNote><Cite><Author>Six</Author><Year>2008</Year><RecNum>459</RecNum><DisplayText>[91]</DisplayText><record><rec-number>459</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">459</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Six, A. J.</author><author>Backus, B. E.</author><author>Kelder, J. C.</author></authors></contributors><auth-address>Zuwe Hofpoort Hospital, Woerden, the Netherlands.</auth-address><titles><title>Chest pain in the emergency room: value of the HEART score</title><secondary-title>Neth Heart J</secondary-title><alt-title>Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation</alt-title></titles><periodical><full-title>Neth Heart J</full-title><abbr-1>Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation</abbr-1></periodical><alt-periodical><full-title>Neth Heart J</full-title><abbr-1>Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation</abbr-1></alt-periodical><pages>191-6</pages><volume>16</volume><number>6</number><edition>2008/07/31</edition><dates><year>2008</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1568-5888 (Print)
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ADDIN EN.CITE.DATA [87]. Table 1EDACS risk calculator?a)?Age (Please Circle SINGLE Best Answer)?18–45+246–50+451–55+656–60+861–65+1066–70+1271–75+1476–80+1681–85+1886?++20b)?Male sex (Please circle if true)+6c)?Aged 18–50 years and either:(i) known coronary artery disease or(ii) ≥3 risk factors+4d)?Symptoms and signs (Circle each if present)?Diaphoresis+3Radiates to arm or shoulder+5Pain occurred or worsened with inspiration?4Pain is reproduced by palpation?6Overall, the clinical use of the chest pain scores has been limited due to complexity and lack of utility. Ideally, a diagnostic score or clinical decision rule should be simple to use and include few subjective variables such as interpretation of the ECG and assessment of chest pain characteristics. In Paper IV we aimed to evaluate a clinical decision rule for rapid exclusion of major cardiac events (MACE) within 30 days from presentation by using the clinical objective rule-out evaluation (CORE) rule, a simplified risk score including age, known arteriosclerosis disease and history of hypertension or diabetes mellitus.Aims of the studyTo evaluate the diagnostic and prognostic performance of hTnT tests in a real-world setting, i.e. in unselected chest pain patients admitted with possible ACS in routine care. (Paper I)To examine the ability of a combination of copeptin and hsTnT to rule out ACS in patients presenting with chest pain, and to compare the diagnostic performance to hsTnT alone. (Paper II)To evaluate if the diagnostic performance of hsTnT for ACS up to 3-4 h after presentation in elderly patients could be improved. (Paper III)To evaluate a simple and objective decision rule for ruling out major adverse cardiac events within 30 days from presentation in unselected ED chest pain patients. (Paper IV)MethodsStudy siteThe Sk?ne University Hospital in Lund is the primary hospital for 300 000 inhabitants. The hospital has a cardiac intensive care unit with 19 beds and an observation unit with 20 beds with ECG monitoring. Percutaneous coronary intervention and coronary artery bypass grafting (CABG) are available 24 h a day. Some 65 000 patients present to the ED per year. Of these, about 6000 present with acute chest pain. A prehospital ECG system is in operation with ambulance ECGs sent to a cardiologist on call. If a STEMI is identified, the patient is transported directly to the angiography laboratory, bypassing the ED.Inclusion of patientsAll patients included in this thesis had non-traumatic chest pain as their main complaint and were older than 18 years. Data were collected from 2010 to 2011 (papers I-III) and from 2013 to 2014 (Paper IV). In Paper I and III, data were retrospectively collected while Paper II and IV were prospective studies. In Papers I-III patients were included in the study database if they were admitted to the cardiac ICU or the observation unit after the initial ED assessment. Patients discharged home directly from the ED were not included. In Paper IV both outpatients and inpatients were included. All patients with missing blood samples, STEMI, cardiac arrest at the ED or living outside the region were excluded from the studies. Clinical assessmentAll patients underwent routine assessment in the ED including physical examination, 12-lead ECG and laboratory analyses including hsTnT. After admission to the observation or the cardiac ICU, all the patients included were subjected to continuous ECG monitoring, pulse oxymetry and noninvasive blood pressure measurements. In paper I-III blood samples for hsTnT analysis were collected at admission and thereafter at the discretion of the attending physician, but mainly after 3–4 and 6–7 h from presentation according to the general practice at the hospital. In Paper IV, clinical data and physician assessments were collected by research assistants (final year medical students supervised senior physicians) using a standardized questionnaire created in accordance with guidelines on chest pain study methodology PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYW5ub248L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [92-94]. The physician assessed whether the ECG had signs of acute ischemia or not. Blood samples for hsTnT analysis were collected at admission and after 2 h from presentation and thereafter at the discretion of the attending physician.Further diagnostic testing and treatment were performed at the discretion of the treating physician.High-sensitivity troponin T assayThe hsTnT analyses were performed with the use of the Elecsys 2010 system (Roche Diagnostics) with a LOD of 5 ng per liter, a 99th-percentile cutoff point of 14 ng per liter, and a coefficient of variation of less than 10 % at 13 ng per liter.?The imprecision at the levels between 3.4-10 ng per liter is reported to be 5-37 % PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWVuZ2VyPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA [52]. In a healthy population, values over the LOD were reported in 61 % PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XZXN0d29vZDwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XZXN0d29vZDwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+
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ADDIN EN.CITE.DATA [95]. The assay was also used in routine care during the study periods. The assay employs two monoclonal antibodies specifically directed against human cardiac troponin T. Total duration of assay is 18 minutes. Falsely low results are obtained when using samples with hemoglobin concentrations > 0.1 g/dL. Except for the occurrence of haemolysis, clinically significant interferences are rare.Copeptin (Paper II)Blood samples drawn at admission were collected and troponin T was determined directly, while copeptin samples were frozen and analysed later. Copeptin were analysed using the BRAHMS copeptin kryptor assay, with a limit of detection of 4.8 pmol/L, a measuring range of 4.8 to 1200 pmol/L and an interassay CV <15% for values <20 pmol/L and <8% for values >50 pmol/L. A copeptin value of <14 pmol/L was used as diagnostic cut-off point in accordance with previous studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA [71, 72] and the manufacturer’s recommendation. The Clinical Objective Rule-out Evaluation (CORE) (Paper IV)In paper IV we evaluated a simple objective rule, the Clinical Objective Rule-out Evaluation (CORE). This rule is based on hsTnT sampled at 2 h after ED presentation and a simplified risk score consisting of four objective parameters; age ≥65 years, known arterial disease or history of hypertension or diabetes mellitus. The components of the risk score were based on previous studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbnRtYW48L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [81, 87, 91] and clinical experience. We only included objective variables in order to minimize the risk of different results depending on the physician. To make the protocol as user-friendly as possible, we designed the stratification system with scores 0 or 1, with the score being the simple arithmetic sum of all variables. Patients younger than 65 years were considered as low risk. This assumption was based on the TIMI and HEART-scores PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbnRtYW48L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [96].Patients with 0 p was considered to be at low risk and eligible for an early discharge from the ED without further investigations.Table 2The Clinical Objective Rule-out Evaluation (CORE)For the patient to be classified as low risk, all criterias have to be met. a. Age <65 yearsb. No history of arterial diseasec. No history of hypertension d. No history of diabetes mellituse. hsTnT ≤ 14 ng/l at 0 or 2 hRecording of patient diagnosis and endpoints In paper I-III the primary combined endpoint was a MACE within 60 d. The MACE was defined as AMI or UA at the index visit, new AMI or UA, non-elective CABG, non-elective PCI or death of all causes. In paper IV the primary endpoint was a MACE defined as AMI, UA, cardiac arrest, cardiogenic shock, ventricular arrhythmia requiring intervention, atrioventricular block requiring intervention, or death of a cardiac or unknown cause within 30 d including the index visit. The final discharge diagnosis was recorded into the database from the discharge summary written by the ward physician and reviewed for quality by the responsible specialist ward physician. The diagnostic criteria for ACS, AMI or UA used at the hospital during the study were those recommended by the ESC, the American College of Cardiology and the American Heart Association PEVuZE5vdGU+PENpdGU+PFllYXI+MjAxMTwvWWVhcj48UmVjTnVtPjgxPC9SZWNOdW0+PERpc3Bs
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ADDIN EN.CITE.DATA [97, 98]. In paper I-III the authors reviewed all diagnoses. In paper IV the final diagnosis was decided by independent reviews of two cardiologists and, in case of disagreement, by a third cardiologist. With the exception of Paper II where the authors were blinded for copeptin, the adjudicated diagnoses were based on all available clinical information.AMI was defined according to the universal definition requiring a significant rise or fall of hsTnT with at least one value above the 99th percentile combined with symptoms of cardiac ischemia, ischemic ECG changes, or imaging evidence of myocardial ischemia PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaHlnZXNlbjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA [4, 22, 98]. In paper I and III a diagnosis of AMI was adjudicated only if there was a 50% increase or decrease in hsTnT when hsTnT elevation was greater than 14 ng/l but less than 50 ng/l,. In patients with an hsTnT greater than 50 ng/l, a 20% increase or decrease was considered sufficient for an AMI diagnosis. In paper III, above 14 ng/l a 20% increase or decrease was needed for an AMI diagnosis. In paper IV all reviewers were provided with the following definitions of significant hsTnT dynamics: An absolute change of > 7 ng/L at 2-3 h, or ≥ 9 ng/L at 6 h PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaWVuZXI8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [47, 99-101], and/or an increase on a 2-6 h sample of > 50 % of the upper reference limit of the assay (which equals > 7 ng/L for hsTnT) if the 0 h hsTnT was < 15 ng/L, or a change > 20 % of the initial value if the 0 h hsTnT was ≥ 15 ng/L (17). In all papers an AMI diagnosis could also be determined in the absence of a significant hsTnT rise or fall the patient presented late with clearly elevated hsTnT and a history consistent with AMI. The UA diagnosis required normal or elevated hsTnT levels without a significant rise or fall and deterioration of previous stable angina, typical chest pain at rest, or a positive cardiac stress test or a stenosis ≥ 70 % on coronary angiography.Follow-up In Region Sk?ne, all hospitals use the same computerized patient record system, and we thereby had access to charts for patients seeking care at any hospital in the region. Deaths and causes of death were obtained from the registers at the Swedish National Board of Health and Welfare. In paper IV we also obtained data from the National Patient Register where all admissions to in-hospital care in Sweden are registered.Statistical analysisContinuous variables are presented as medians (with interquartile range) and were compared using the Mann–Whitney U-test. For patient characteristics, categorical variables were compared using the Pearson Chi-square test.In the assessment of the time-dependent diagnostic and prognostic performance, sensitivity, specificity, negative predictive values (NPV) and positive predictive values (PPV) with 95% confidence intervals (CI) were calculated. Sensitivity and specificity were compared with McNemar test in Paper II. IBM SPSS Statistics 18 (IBM, New York, New York, USA) and Microsoft Excel software was used for all statistical analyses, and a P value less than 0.05 was considered statistically significant.Results Diagnostic performance of hsTnT for ACS in real life(Paper I)A total of 792 chest pain patients were admitted to the cardiac intensive care unit or the observation unit, and 773 were included in the final analysis. A complete series of tests at 0, 3-4 and 6-7 h were obtained in 278 patients. ACS was more common in this selected population compared to the total group (28% vs 23%), as was hypertension and previous coronary artery disease. The fraction of males and patients ≥ 75 years, and the GRACE score median, were similar.Figure 7 describes the diagnostic performance of hsTnT ≤ 14 ng/L for ACS at presentation, at 3-4 h and at 6-7 h. Sensitivity for ACS at 6-7 h was only 81 %. Analysis of AMI alone, as compared to ACS, increased the sensitivity on admission from 68 to 80 %, and at 3-4 h from 79 to 97 %. The NPV on admission increased from 85 to 93 %, and at 3-4 h from 89 to 99 %. Patients with ACS and no elevation of hsTnT after 6-7 h (n=15) were patients with UA in all cases but one. The UA patients underwent CABG more often than those with NSTEMI indicating more frequent multi-vessel disease in the UA group.At 60 days, 13 of the 773 patients had died. None of these patients had a normal hsTnT at presentation. Fourteen (1.8 %) of the 773 patients had an endpoint after the initial hospital stay but within 60 days. Eight of these patients re-presented to the ED with ACS, and none died. SensSpecPPVNPVAccurLR+LR-Admission0.680.690.460.850.692.190.463-4 h 0.79 a 0.65 b0.470.890.692.270.326-7 h 0.81 c 0.65 d0.470.900.692.280.30a p < 0.012 vs sensitivity at admission b p < 0.039 vs specificity at admissionc p > 0.5 vs sensitivity at 3-4 hd p > 0.5 vs specificity at 3-4 h Figure 7. Diagnostic performance of hsTnT for ACS during hospital stay in 278 patients at admission, at 3-4 and at 6-7 h. PPV, positive predictive value; NPV, negative predictive value; Accur, accuracy, LR+, positive likelihood ratio; LR-, negative likelihood ratio.Diagnostic performance for ACS in the elderly (Papers I and III)In paper I, we evaluated the diagnostic performance of hsTnT in a subgroup of elderly patients. Two hundred and forty (31 %) patients were ≥ 75 years. Of these, 59 patients (24 %) had ACS during the hospital stay and among these, 13 patients had UA. As seen in Figure 8, the sensitivity of hsTnT ≤ 14 ng/L on admission for ACS was higher in patients ≥ 75 years compared to patients < 75 years (n=533). However, the specificity on admission was significantly lower in those ≥ 75 years (41 %) than in those < 75 years (79 %). Among patients ≥ 75 years, 150 patients (63 %) had a hsTnT > 14 ng/L on admission, but only 59 (39 %) of these had an ACS during the initial hospital stay.Sens Spec PPV NPV Accur LR+ LR- nPatients ≥ 75 yearsAdmission0.800.410.310.860.511.350.492343-4 h0.870.340.300.890.471.330.381546-7 h0.860.360.350.860.501.340.40121Patients < 75 yearsAdmission 0.66 * 0.79 **0.470.890.763.140.435233-4 h0.790.810.560.920.804.050.263576-7 h0.770.780.540.910.783.520.30257* p= 0.07 vs sensitivity at admission in patients ≥ 75 years ** p = 0.001 vs specificity at admission in patients ≥ 75 years Figure 8. Diagnostic performance of hsTnT for ACS at 0, 3-4 and 6-7 h from admission in patients < 75 and ≥ 75 years. PPV, positive predictive value; NPV, negative predictive value; Accur, accuracy, LR+, positive likelihood ratio; LR-, negative likelihood ratio.In paper III, 477 patients ≥ 75 years with suspected ACS were studied. Twenty-seven percent of the patients had ACS and 21 % AMI during the hospital stay. Twenty-five patients (5 %) were considered to have type 2 AMI. One hundred and forty-three patients (30 %) had a MACE within 2 months. Six patients were diagnosed with ACS and twelve patients died after the initial stay but within 2 months. The causes of death were not registered.There were no significant differences in prior cardiovascular disease between patients with and without ACS. Male sex was significantly more common and warfarin treatment significantly less common in the ACS group. Average age was similar in patients with and without ACS, but GRACE score was significantly higher in the group with ACS. Only 49 of the patients with ACS (38 %) presented with ECG changes not known to be old.In Table 3, panel a, it can be seen that with the cut-off 14 ng/L, the sensitivity for ACS was 88 % at 3-4 h, with a specificity of 38 %. Analysing for NSTEMI alone (panel b) gave a sensitivity and NPV of 100 % but did not improve specificity and PPV. When diagnostic performance for all AMI (NSTEMI and Type 2 AMI) was analysed (panel c), sensitivity and NPV again reached 100 % but specificity remained low at 41%. Using the cut-offs 20 and 30 ng/L decreased sensitivity and increased specificity for all endpoints.Table 3Diagnostic performance for ACS (a), NSTEMI (b), all AMI (c) and MACE after 2 months (d) of HsTnT analysed at 3-4 h. HsTnT, high-sensitivity troponin T; AMI, acute myocardial infarction; NSTEMI, non-ST-elevation myocardial infarction. All AMI includes NSTEMI and Type 2 AMI. MACE, NSTEMI, non-elective PCI, non-elective CABG and death within 2 months.a) ACS prediction at 3-4 h n= 77Sensitivity(95% CI)Specificity(95% CI)NPV(95% CI)PPV(95% CI)HsTnT> 1488(78-94)38(32-44)90(83-95)32(26-35)> 2081(70-88)58(52-65)90(84-90)39(31-47)> 3077(65-85)75(69-80)91(86-94)50(41-59)b) NSTEMI prediction at 3-4 h n= 61HsTnT > 14100(93-100)39(33-45)100(95-100)28(22-35)> 2093(83-98)59(53-65)97(93-9936(28-44)> 3090(79-96)75(69-80)97(93-99)47(37-56)c) All AMI prediction at 3-4 h n= 81HsTnT > 14100(94-100)41(35-48)100(95-100)36(32-43)> 2094(85-98)63(56-69)97(92-99)45(37-53)> 3090(80-95)80(73-84)96(92-98)58(49-67)d) MACE prediction at 3-4 h n= 86HsTnT > 1491(83-96)39(33-46)93(85-97)35(29-42)> 2083(73-90)60(54-66)91(85-95)42(35-51)> 3077(66-85)77(70-81)90(85-94)53(44-63)In an attempt to improve specificity and PPV for NSTEMI, a single hsTnT value at presentation was combined with the absolute hsTnT change from 0 to 3-4 h. Figure 9 shows that area under the ROC curve was larger for absolute than for relative hsTnT changes from 0 to 3-4 h. Figure 9. ROC curves for AMI prediction of absolute and relative HsTnT changes from presentation to 3-4 h. Areas under the curves: 0.94 (95% confidence interval 0.899-0.972) for absolute HsTnT change and 0.82 (95% confidence interval 0.759-0.885) for relative change.The diagnostic performance for the combination of hsTnT at presentation and the absolute hsTnT change from 0 to 3-4 h is shown in Table 4. Combining hsTnT at presentation > 30 ng/L and/or a change > 5 ng/L gave a 63 % specificity and a PPV of 46 %, a 99 % sensitivity and a NPV of 99 % for NSTEMI. On the assumption that 98 % sensitivity is acceptable in routine care, these criteria would allow NSTEMI to be ruled out at 3-4 h in 47 % of the patients with a sensitivity of 99%.Increasing the cut-offs for the initial hsTnT or the absolute change decreased the sensitivity to less than 98%. Table 4Diagnostic performance for NSTEMI with analysis at single time points and/or changes. HsTnT, high-sensitivity troponin T; NSTEMI, non-ST-elevation myocardial infarction; abs Δ to 3-4 h, absolute change TnT from admission to 3-4 hours. A sensitivity of ≥ 98 % are considered acceptable rule out levels. Best diagnostic performance is marked with grey.Sensitivity(95% CI)Specificity(95% CI)NPV(95% CI)PPV(95% CI)HsTnT at presentation > 14and/or abs Δ to 3-4 h> 599(93-100)30(25-36)99(94-100)30(25-35)>798(92-100)32(27-38)98(92-100)30(25-36)>996(89-99)32(27-38)96(90-99)30(25-35)HsTnT at presentation> 20and/or abs Δ to 3-4 h> 599(93-100)46(41-52)99(96-100)36(30-43)>798(92-100)49(43-54)99(95-100)37(31-44)>996(89-99)49(43-54)97(93-99)37(31-43)HsTnT at presentation> 30and/or abs Δ to 3-4 h> 599(93-100)63(57-68)99(96-100)46(40-54)>797(90-99)66(60-72)98(95-100)48(41-56)>994(87-98)67(61-72)97(94-99)48(41-56)HsTnT at presentation > 40and/or abs Δ to 3-4 h> 595(88-98)70(64-76)98(94-99)51(43-59)>791(82-96)75(70-80)96(92-98)54(46-62)>988(80-94)76(70-81)95(91-98)54(46-63)HsTnT at presentation was pathological in more than 50 % with the patients not having ACS. Elevated hsTnT levels were very common in patients with pneumonia, pulmonary embolism and heart failure. All patients with type 2 AMI had clinical conditions that made in-hospital care necessary regardless of the hsTnT value.Diagnostic performance of high sensitivity troponin T and copeptin for early rule-out of ACS(Paper II)In this study, 478 patients were included and 107 patients (22%) were diagnosed with ACS during the hospital stay. Of these, 69 patients (14%) had NSTEMI and 37 patients (8%) had UA. As seen in Table 5, the combination of hsTnT >14 ng/L or copeptin ≥14 pmol/L at presentation identified ACS, NSTEMI and UA with a higher sensitivity than hsTnT alone. Sensitivity and NPV for ACS and UA was low for both hsTnT alone and for the combination of hsTnT and copeptin.Table 5 Diagnostic performance for ACS, NSTEMI and UA for hsTnT alone and the combination of hsTnT and copeptin at presentation. Sensitivity, Specificity, NPV and PPV are given with corresponding 95% confidence interval. NPV: negative predicitive value; PPV: positive predicitive value; ACS: acute coronary syndrome NSTEMI: non ST-elevation myocardial infarction; UA: unstable angina.?hsTnT ≤14 ng/LhsTnT ≤14 ng/L and Copeptin <14 pmol/Lp-value (n= 478)(n= 478)ACSSensitivity 69 (59-77)83 (74-89)<0,001Specificity70 (65-75)50 (45-55)<0,001NPV89 (84-92)91 (86-94)PPV40 (33-47)32 (27-38)NSTEMISensitivity87 (76-93)96 (86-98)0,031Specificity69 (65-74)49 (44-54)<0,001NPV97 (94-98)99 (95-99)PPV32 (26-40)24 (19-30)UASensitivity35 (20-52)59 (42-74)0,004Specificity61 (56-66)43 (38-48)<0,001NPV92 (88-95)93 (87-95)PPV7 ( 4-12)8 (5-12)In Table 6 it can be seen that sensitivity and NPV for a repeated hsTnT analysed 3-4 hours after presentation was equal to the combination of hsTnT and copeptin at presentation for all endpoints. Specificity and PPV were lower with the combination compared to hsTnT alone.Table 6. Diagnostic performance for ACS, NSTEMI and UA for hsTnT analysed 3 to 4 hours after presentation and the combination of troponin and copeptin at presentation. Sensitivity, Specificity, NPV and PPV are given with corresponding 95% confidence interval. NPV: negative predicitive value; PPV: positive predicitive value; ACS: acute coronary syndrome NSTEMI: non ST-elevation myocardial infarction; UA: unstable angina.?hsTnT≤14 ng/L and Copeptin<14 pmol/L at presentationhsTnT≤14 ng/L after 3-4 hoursp-value(n=309)(n=309)ACSSensitivity 86 (74-92)77 (65-86)0,031Specificity50 (44-56)68 (62-74)<0,001NPV92 (85-96)91 (86-95)PPV33 (26-40)41 (32-50)NSTEMISensitivity98 (87-100)98 (87-100)1Specificity49 (43-55)68 (62-73)<0,001NPV99 (95-100)99 (96-100)PPV25 (19-32)35 (27-44)UAPSensitivity61 (39-80)35 (17-57)0,031Specificity42 (37-48)57 (51-63)<0,001NPV93 (87-97)92 (86-95)PPV8 (5-13)6 (3-12)The Clinical Objective Rule-out Evaluation (CORE) (Paper IV)There were 751 patients included in this study. A MACE within 30 days occurred in a total of 90 (11.9%) patients within 30 days. NSTEMI was the most common MACE (63 %) and twice as common as UA (31 %). In Table 7, the diagnostic accuracy for the CORE rule, combining the simplified risk score and hsTnT are shown. The CORE rule identified 248 (33%) of patients as low risk of with a sensitivity of 98.9% and a negative predictive value (NPV) of 99.6% for MACE. There was only one (0.4%) patient identified as low risk who had a MACE within 30 days. This patient was a previously healthy 60-year-old male who presented after 2 h of chest pain, and was eventually diagnosed with UA. During the index visit the patient had a stress test and echocardiography before an emergency CABG was performed. A strategy including only hsTnT and ECG, identified 504 (67%) patients as low risk but with an unacceptably low sensitivity. As it can be seen in the table, sensitivity was 88.9% and NPV was 98%. Adding the ED physician’s interpretation of the ECG to CORE did not improve diagnostic performance.Table 7 Diagnostic accuracy of ECG, hs-cTnT and three different diagnostic strategies.Sensitivity, Specificity, NPV and PPV are given with corresponding 95% confidence interval. NPV: negative predicitive value; PPV: positive predicitive value; hsTnT: high-sensitivity cardiac troponin; ECG: electrocardiogram; CORE: the clinical objective rule-out evaluation. ECG aloneHsTnT aloneHsTnT + ECGCORE rule (score + HsTnT)CORE rule + ECGSensitivity(95% CI)32.2(23.0–43.0)86.7(77.5–92.6)88.9(80.0-94.3)98.9(93.1–99.9)98.9(93.1 – 99.9)Specificity(95% CI)97.1(95.4–98.2)77.0(73.6–80.1)74.7(71.2-78.0)37.4(33.7–41.2)36.9(33.2 – 40.7)NPV(95% CI)91.2(88.8–93.2)97.7(95.9–98.7)98.0(96.3-99.0)99.6(97.4–100)99.6(97.4 - 100)PPV(95% CI)60.4(45.3-73.9)33.9(27.9-40.5)32.4(26.7-38.7)17.7(14.6-21.4)17.6(14.4–21.3)DiscussionThe overall aim of this PhD project was to increase the understanding of the strengths and weaknesses of hsTnT and copeptin as early diagnostic tools in patients with possible acute coronary syndrome. There are five major findings in this thesis. First, a single hsTnT analysis at 3-4 h from presentation can exclude NSTEMI in unselected ED patients with excellent accuracy. Second, the combination of hsTnT and copeptin can exclude NSTEMI already at presentation and the diagnostic performance is equivalent to hsTnT alone analysed at 3-4 h. 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ADDIN EN.CITE.DATA [28, 31, 32, 36] were not primarily designed to study the optimal time for blood sampling we wanted to evaluate the diagnostic performance of hsTnT in unselected chest pain patients admitted with possible ACS in routine care. We found that NPV for NSTEMI of hsTnT ≤ 14 ng/l at 3-4 h was 99 % for all ages and 100 % for patients > 75 years. In patients > 75 years NSTEMI could be excluded by a hsTnT value ≤ 20 ng/l at 3-4 h with a NPV of 97%.Our data confirm that prolonged testing with biomarkers after 3-4 h is no longer needed when using a high sensitive assay. A hsTnT value ≤ 14 ng/l at 3-4 h practically rules out AMI and the finding is in line with previous studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA [28, 31, 32, 36, 53, 56, 58, 102]. ACS however, cannot be excluded with the rapid 3 h hsTnT sampling protocol, see below under “ACS cannot be excluded by biomarkers alone”. Diagnostic accuracy for rule out of NSTEMI of hsTnT and copeptin at presentation is equivalent to hsTnT analysed at 3-4 h Cardiac troponins are released after myocardial cell disintegration and are markers of cell necrosis. This may be the reason for the relative weakness in diagnostic performance in patients presenting early after chest pain onset. Our studies indicate that NSTEMI can be excluded with excellent precision using either the combination of hsTnT and copeptin at presentation or by a second sample with hsTnT after 3 hours. In paper I-III, NPV for ruling out NSTEMI was as high as 99% and this is in line with several other studies on hsTnT alone PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [71-74, 76]. By using the combination of hsTnT and copeptin at presentation instead of a repeated hsTnT test, three hours of observation could theoretically be spared per patient. This must however be set against the difficulties and costs for implementation of a new biomarker assay. In addition, the lower specificity for the combination of hsTnT and copeptin compared to hsTnT alone is a considerable shortage.ACS cannot be excluded by current biomarkers alone An important dimension for all papers in this thesis is that UA were included in all endpoints. Most studies on both hsTnT alone PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [103] and to our knowledge; no study has shown that patients with UA can safely be discharged from the ED without further investigation and treatment.For hsTnT alone the sensitivity for ACS was low at all time points compared to the sensitivity for NSTEMI alone. The ESC rapid rule-out protocol for NSTEMI failed to identify 20 % of the patients with ACS in our study, even at 6-7 h after presentation. The present findings highlight the inherent problem with using a marker of myocardial necrosis to rule out acute coronary disease. The combination of hsTnT >14 ng/L or copeptin ≥14 pmol/L at presentation identified ACS with a sensitivity of 83 % and a NPV of 91 %. These results are in accordance with previous studies from Keller and Reichlin PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [71] reported a NPV of 80% for ACS when combining a conventional troponin T test and copeptin in a very small study population. Ours is the first larger study using the combination of hsTnT and copeptin for ruling out ACS and not only NSTEMI. Based on the combination of hsTnT and copeptin alone, 18 out of 107 patients (9 %) with ACS would have been misdiagnosed as non-ACS in our study and our conclusion is that current biomarkers alone are unable rule out ACS.Reichlin et al PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA [72] reported no significant difference in copeptin concentration between UAP patients and patients with other diagnoses than ACS and attributed this to that UAP does not cause sufficient endogenous stress for vasopressin release.In study III, we found that the sensitivity for ACS in the elderly was higher than for the general population in study I, but sensitivity still did not exceed 90 %. In elderly patients it is even more difficult to achieve a robust diagnosis of ACS (UA) since elderly patients often do not undergo coronary angiography due to the inherent risks. We therefore also evaluated the diagnostic performance of hsTnT for MACE within 2 months. Sensitivity and NPV for 60-day MACE were similar to those for ACS during the index visit indicating that excluding NSTEMI at the ED is not sufficient for optimal care, even if the 2-month follow-up in this study was quite generous. Diagnostic performance for hsTnT and copeptin as a rule in tool for ACS is poor.In all studies in the thesis, a considerable number of patients presented with a hsTnT value > 14 ng/L unrelated to ACS, especially among patients ≥ 75 years. We found a lower specificity of hsTnT for AMI than the studies referred to in the ESC guidelines PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [28, 31, 32, 36]. The low specificity in our studies could be explained by an older population with more comorbidities, and that the exclusion criteria were few, as in routine care. Like in previous studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWhybWFubjwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+
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ADDIN EN.CITE.DATA [53, 56, 104], we found a positive hsTnT to be very common among elderly patients; 63 % of those ≥ 75 years had elevated hsTnT levels on admission. Further, less than one third of these positive tests were true positive (PPV 31%). Elderly patients are common in all EDs, and in our unselected material 31 % of the patients were ≥ 75 years.These patients could be at risk for unnecessary admission to in-hospital care, over-investigation and over-treatment with anticoagulant and antiplatelet drugs for ACS. In paper III we further wanted to evaluate the diagnostic performance of hsTnT in the elderly. In this study we hypothesised that either adjusted cut-offs, or a combination of adjusted initial hsTnT results and the change from 0 to 3-4 h could improve diagnostic performance for rule in. We found that hsTnT cannot be used to rule in NSTEMI during the initial 3-4 h using either standard or adjusted cut-offs, or a combination of the initial hsTnT result and the change from 0 to 3-4 h. Using the standard cut off 14 ng/L, the ability of a single hsTnT to rule in both NSTEMI and all AMI was poor, since specificities and PPVs were below 50 %. This low specificity of hsTnT for AMI (and ACS) confirms previous results by Bahrmann ADDIN EN.CITE <EndNote><Cite><Author>Bahrmann</Author><Year>2011</Year><RecNum>14</RecNum><DisplayText>[53]</DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">14</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bahrmann, P.</author><author>Heppner, H. J.</author><author>Christ, M.</author><author>Bertsch, T.</author><author>Sieber, C. C.</author></authors></contributors><auth-address>Department of Geriatric Medicine, Nuremberg Hospital, Germany.</auth-address><titles><title>Early detection of Non-ST-Elevation Myocardial Infarction in geriatric patients by a new high-sensitive cardiac Troponin T assay</title><secondary-title>Aging Clin Exp Res</secondary-title><alt-title>Aging clinical and experimental research</alt-title></titles><periodical><full-title>Aging Clin Exp Res</full-title><abbr-1>Aging clinical and experimental research</abbr-1></periodical><alt-periodical><full-title>Aging Clin Exp Res</full-title><abbr-1>Aging clinical and experimental research</abbr-1></alt-periodical><edition>2011/09/29</edition><dates><year>2011</year><pub-dates><date>Sep 26</date></pub-dates></dates><isbn>1594-0667 (Print)
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ADDIN EN.CITE.DATA [58], and is also well described in the meta-analysis by Sethi et al PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZXRoaTwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [105]. We also evaluated a combination of a higher hsTnT cut-off at presentation and a low hsTnT change up to 3-4 h in order to reduce the number of false positive tests. In this way, patients without AMI but with an elevated baseline troponin level were not classified as AMI, while AMI patients with low baseline hsTnT values could still be identified by the hsTnT change. With the combined criteria specificity and PPV improved, but it seems unlikely that they will improve clinical care. With combined criteria, PPV still did not reach more than 46 % when aiming at a sensitivity of ≥ 98%. We agree with Rains et al. that it is not possible to assign a working diagnosis of AMI using only troponin in the elderly ADDIN EN.CITE <EndNote><Cite><Author>Rains</Author><Year>2014</Year><RecNum>233</RecNum><DisplayText>[51]</DisplayText><record><rec-number>233</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">233</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rains, M. G.</author><author>Laney, C. A.</author><author>Bailey, A. L.</author><author>Campbell, C. L.</author></authors></contributors><auth-address>Gill Heart Institute, Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.
Gill Heart Institute, Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA ; Lexington Veterans Administration Hospital, Lexington, KY, USA.</auth-address><titles><title>Biomarkers of acute myocardial infarction in the elderly: troponin and beyond</title><secondary-title>Clin Interv Aging</secondary-title><alt-title>Clinical interventions in aging</alt-title></titles><periodical><full-title>Clin Interv Aging</full-title><abbr-1>Clinical interventions in aging</abbr-1></periodical><alt-periodical><full-title>Clin Interv Aging</full-title><abbr-1>Clinical interventions in aging</abbr-1></alt-periodical><pages>1081-90</pages><volume>9</volume><edition>2014/07/24</edition><keywords><keyword>Aged</keyword><keyword>Aging/*blood</keyword><keyword>Biological Markers/blood</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/*blood/*diagnosis</keyword><keyword>Troponin I/*blood</keyword><keyword>Troponin T/*blood</keyword></keywords><dates><year>2014</year></dates><isbn>1178-1998 (Electronic)
1176-9092 (Linking)</isbn><accession-num>25053882</accession-num><work-type>Review</work-type><urls><related-urls><url>;[51].Low risk patients can be identified with the Clinical Objective Rule-out Evaluation (CORE)One important issue for the emergency physician is to identify patients without serious conditions suitable for early discharge with no need of further investigation. As we stated above, biomarkers alone cannot rule out ACS in unselected chest pain patients. The Clinical Objective Rule-out Evaluation (CORE) evaluates not only the risk of AMI but also the risk of a MACE within 30 days. One-third of all chest pain patients were identified as having a very low 30-day risk of MACE with the CORE decision rule and these patients may potentially be discharged from the ED without additional investigation for ACS. The CORE rule thereby has the potential to shorten the length of ED stay and in particular, reduce the need of additional investigations and costs.Another finding in this study was that adding the ECG to CORE did not improve sensitivity or NPV for MACE. It is known that many ACS patients have a non-ischemic ECG PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWljaGxpbjwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+
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ADDIN EN.CITE.DATA [67, 103], and it is reasonable to believe that this has become even more common after the introduction of high sensitivity troponins. Only a third of the MACE cases in this study had an ischemic ECG at the ED (sensitivity 32 %). The specificity of the ECG has probably also decrease over time since pathological ECGs are most likely more frequent due to the ageing population and improved cardiac care. In addition, misinterpretation of the ECG is relatively common PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XZXN0ZHJvcDwvQXV0aG9yPjxZZWFyPjE5OTI8L1llYXI+
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ADDIN EN.CITE.DATA [87] scores. These scores have a high sensitivity for selected endpoints and have all accurately identified between 10-40 % of patients as low risk for death and/or AMI. The TIMI risk score was originally designed for patients with established ACS whereas newer scores like HEART, EDACS and the Vancouver rule were specifically developed for unselected ED chest pain patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWhsZXI8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [83-88, 91]. These scores have potential disadvantages in routine care and none of them are widely used in clinical practice. The HEART-score and the EDACS-ADP are both hard to use without electronic assistance and include subjective variables PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWNrdXM8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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AG==
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ADDIN EN.CITE.DATA [88, 108]. The TIMI score has an additive scoring system and a binary outcome, but includes the subjective variable “≥ 2 episodes of severe angina within the last 24 h”, and also “aspirin use within 7 days”, which many clinicians find counterintuitive as a risk factor.The CORE decision rule seems to have the requirements needed for a clinical setting. In this study CORE was evaluated in the ED but the decision rule could also be tested and validated prospectively in individuals suspected of having ACS in a primary care setting. Further, it would be interesting to evaluate a point of care analysis of hsTnT within the CORE rule.Before clinical implementation of the CORE rule, prospective validation in routine care is needed. Conclusion and future directionsThe first three real life studies in this thesis are important complements to previous prospective studies in less generalisable settings PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXI8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [31, 32, 56, 71, 72, 102]. The findings support that hsTnT is useful in the early rule out of NSTEMI in both unselected and elderly ED patients. In combination with copeptin, hsTnT can exclude NSTEMI but not ACS already at presentation. In contrast, a single value of hsTnT, or the combination of hsTnT and copeptin, cannot be used to rule in NSTEMI or ACS in an unselected ED population. In elderly patients, a higher cut off or a combination of a higher cut-off and the early hsTnT change improves specificity and PPV but not to a clinically valuable extent. Our simple decision rule CORE can correctly identify one third of chest pain patients in the ED as needing no further investigation for acute coronary disease. In conclusion, our studies have led to a better understanding of the strengths and weaknesses of hsTnT as an early diagnostic tool in patients with possible ACS.It is important to highlight that results from this study are restricted to patients with chest pain as their main complaint. However, it is well known that elderly ACS patients often have atypical symptoms such as shortness of breath or fatigue ADDIN EN.CITE <EndNote><Cite><Author>Carro</Author><Year>2011</Year><RecNum>198</RecNum><DisplayText>[109]</DisplayText><record><rec-number>198</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">198</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carro, A.</author><author>Kaski, J. C.</author></authors></contributors><auth-address>Cardiovascular Sciences Research Centre, Division of Clinical Sciences, St George's University of London, London, United Kingdom.</auth-address><titles><title>Myocardial infarction in the elderly</title><secondary-title>Aging Dis</secondary-title><alt-title>Aging and disease</alt-title></titles><periodical><full-title>Aging Dis</full-title><abbr-1>Aging and disease</abbr-1></periodical><alt-periodical><full-title>Aging Dis</full-title><abbr-1>Aging and disease</abbr-1></alt-periodical><pages>116-37</pages><volume>2</volume><number>2</number><edition>2012/03/08</edition><dates><year>2011</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>2152-5250 (Electronic)
2152-5250 (Linking)</isbn><accession-num>22396870</accession-num><urls><related-urls><url>;[109].The hsTnT assay was introduced at our university hospital in 2010. The sensitivity of the method permits measurement of cTn concentrations even in a significant number of healthy individuals. This creates problems in the real life management of unselected chest pain patients. Clinicians have to learn how to deal with the high sensitive assays and the introduction of hsTn has increased the responsibility of the clinician to interpret the test in clinical context. There is no doubt that the new hsTn assays have shortened the hospital stay for a number of patients, but due to its low specificity patients will be at risk of harmful and unnecessary investigations and treatments. These risks are most apparent for elderly patients. Many ED patients without chest pain as their main complaint will have a hsTnT test taken as a part of standard care. The diagnostic accuracy in this setting is not evaluated in this thesis and the value of introducing hsTnT under these circumstances needs to be clarified.For optimal use of hsTn, there are some major questions that have to be answered. Is it possible to introduce age- and sex-specific upper reference limit cut-offs? Does a specific change of hsTn exist for ruling in AMI or ACS? If not, we must look for a new biomarker that is specific for the etiology of cardiac cell death in ACS, i.e. acute myocardial ischemia.Does hsTn assays in routine clinical practice improve patient outcome? In a study by Sanchis et al. hsTnI was compared to a conventional TnI. HsTnI simplified chest pain management by reducing non-invasive tests but led to longer hospitalization and more invasive procedures with no impact on 6-month outcome ADDIN EN.CITE <EndNote><Cite><Author>Sanchis</Author><Year>2014</Year><RecNum>719</RecNum><DisplayText>[110]</DisplayText><record><rec-number>719</rec-number><foreign-keys><key app="EN" db-id="rxs9v0vzerwwpyefw27xfdp6vvextrfp9rz9">719</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sanchis, J.</author><author>Garcia-Blas, S.</author><author>Mainar, L.</author><author>Mollar, A.</author><author>Abellan, L.</author><author>Ventura, S.</author><author>Bonanad, C.</author><author>Consuegra-Sanchez, L.</author><author>Roque, M.</author><author>Chorro, F. J.</author><author>Nunez, E.</author><author>Nunez, J.</author></authors></contributors><auth-address>Cardiology Department, Medicine Department, University Clinic Hospital, INCLIVA, Valencia University, Valencia, Spain.</auth-address><titles><title>High-sensitivity versus conventional troponin for management and prognosis assessment of patients with acute chest pain</title><secondary-title>Heart</secondary-title></titles><periodical><full-title>Heart</full-title></periodical><pages>1591-6</pages><volume>100</volume><number>20</number><edition>2014/06/21</edition><keywords><keyword>Acute Disease</keyword><keyword>Aged</keyword><keyword>Chest Pain/*blood/*therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Prognosis</keyword><keyword>Prospective Studies</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Troponin/*blood</keyword></keywords><dates><year>2014</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1468-201X (Electronic)
1355-6037 (Linking)</isbn><accession-num>24947318</accession-num><work-type>Comparative Study
Research Support, Non-U.S. Gov't</work-type><urls><related-urls><url>;[110]. To our knowledge, potential benefits with hsTnT such as earlier diagnosis, more adequate monitoring and shorter times to invasive treatment, leading to reduced morbidity and mortality have not been demonstrated in any study, despite a considerable number of published papers.The management of chest pain patient is the subject of intense research. New biomarkers will be developed and evaluated, and hopefully some of them will be more specific for ACS. If not, this author believes that the separation of type 1 and typ 2 AMI should be deleted from future terminology. A type 2 AMI is not one condition but several and they only have one thing in common; myocardial cell death. It is the underlying condition that should be the primary target for treatment and not the heart.Decision rules like the CORE rule have the potential to improve acute chest pain management, but in the end prediction models will only improve the quality and the cost-effectiveness of care when the provided information improves the physician’s decision-making. This needs to be analysed in prospective studies in routine care.AcknowledgementProfessor Ulf Ekelund, my supervisor, for teaching and tutorship with great skills. Without your patience and encouraging attitude this thesis would never have been completed.Professor David Erlinge, my co-supervisor, for guiding me into the world of science. Thank you for the support in times when I was ready to give up.My fellow researcher Arash Mokhtari, for invaluable help and excellent research collaboration.Bertil ?hlin (1963-2015), my former friend and colleague, for facilitating the opportunity to carry out research and for making me realize that research and scientific curiosity is a part of a practicing clinician?s every day work. My co-authors Katarina Lockman-Frostred, Knut Kollberg, Johan Thelin and David Larsson for valuable contribution to the thesis. Patrik Tydén and Patrik Gilje for great support to parts of the project.My opponent during the half-time review, Oscar Braun, for valuable feedback and comments.Our research nurses Kerstin Roos and Mahin Akbarzadeh for valuable help with data collection.Susann Ullén for statistical support. Ulf Ekstr?m, for teaching me about clinical chemistry and troponin analysis in particular.Natasa Olsson for practical support.The ED staff for collecting blood samples and for their never ending caring of the chest pain patients. All the staff at MAVA, my second home during many years. Johan Elf, Katarina Fagher, Grunde Gjesdal Karin Olsson, Jadwiga Mroczkowska, Hans-J?rgen Nilsson and Johan Svahn for being my dearest colleagues and the best professional company both during work and after.G?ran Eklundh, Bo Erwander and Rolf Linné for being invaluable mentors in clinical practice. I would not have been the physician I am today without you. Steen Ekdahl, Peter Kalén, Fredrik Johansson, Susanne Magnusson and all the colleagues in Helsingborg for enabling me to do research in Helsingborg. PSG (Ann Svensson, Annika Widerberg and Jessica Hultgren), the inspiring Patient Safety Group in Sk?nev?rd Sund for being patient with my sometimes mental and physical absence during the last year.The patients for their participation in this thesis.My dog Ester for healthy breaks during intense research periods.And finally, Petter, Oskar, August and Emil because you are everything that matters in life. This work was supported by the Medical Faculty at Lund University, Region Sk?ne FoU, an ALF grant at The Sk?ne University Hospital in Lund, the Laerdal foundation and the Swedish Heart and Lung foundation..Popul?rvetenskaplig sammanfattningHj?rtk?rlsjukdom ?r den vanligaste d?dsorsaken i v?stv?rlden och en stor kostnad f?r samh?llet. F?rekomsten av hj?rtk?rlsjukdom ?kar och detta har flera f?rklaringar, bla en ?kad medellivsl?ngd, r?kning, minskad fysisk aktivitet och oh?lsosamma matvanor. Instabil kransk?rlssjukdom omfattar tv? begrepp, akut hj?rtinfarkt och instabil k?rlkramp (angina). Tillst?ndet beror p? f?r?ndringar i hj?rtats kransk?rl och resulterar i hastigt f?rs?mrad blodcirkulation till hj?rtmuskeln. Varje ?r s?ker ca 15 miljoner m?nniskor i USA och Europa v?rd pga br?stsm?rta, ett vanligt symptom vid akut hj?rtinfarkt. Hj?rtinfarkt ?r ett allvarligt tillst?nd som varje l?kare m?ste kunna diagnostisera. Eftersom endast ca 10% av patienter med br?stsm?rta visar sig ha hj?rtinfarkt, ligger sv?righeten i att hitta de patienter som har hj?rtinfarkt bland alla de som s?ker. F?ljden blir att m?nga patienter m?ste stanna p? sjukhus f?r observation och ibland genomg? riskfyllda och dyra unders?kningar i on?dan. Det finns ett stort behov av enkla och s?kra verktyg f?r att tidigt identifiera de patienter som drabbats av hj?rtinfarkt men ocks? att hitta de patienter som inte beh?ver ytterligare utredningar. Skulle vi lyckas med detta kommer m?nga patienter slippa l?nga vistelsetider p? akutmottagningar och sjukhusavdelningar. Under 2010 introducerades ett nytt blodprov f?r hj?rtinfarktdiagnostik, sk h?gsensitivt troponin (hsTnT) p? Sk?nes Universitetssjukhus. Troponin ?r ett ?mne som finns bundet i hj?rtmuskeln och som fris?tts i samband med en hj?rtmuskelskada. HsTnT ?r en utveckling av en tidigare metod som anv?nts under flera ?r. Nackdelen med den ?ldre metoden ?r att precisionen i blodprovet ?r mindre exakt vid l?gre koncentrationer, ex i tidigt skede av en hj?rtinfarkt. Detta medf?r att det kan ta flera timmar innan en diagnos kan st?llas. Den nya metoden ger en h?gre precision vid l?gre koncentrationer i blodet och det i sig m?jligg?r en tidigare diagnos. Inf?randet av den nya metoden medf?r dock att ?ven m?nga patienter utan hj?rtinfarkt uppvisar f?rh?jda koncentrationer i blodet. I v?r f?rsta studie ville vi s?kerst?lla att den Europeiska kardiologf?reningens rekommendationer f?r att utesluta instabil kransk?rlssjukdom (The 2011 European Society of Cardiology (ESC) guidelines) g?llde ?ven f?r v?ra patienter vid v?r akutmottagning. Rekommendationerna innebar att det var tillr?ckligt att f?lja blodprover upp till tre timmar efter ankomsten till sjukhus, att j?mf?ra med sex till tolv timmar med den ?ldre metoden. I v?r studie fann vi att tre timmar var tillr?ckligt f?r att utesluta en manifest hj?rtinfarkt men inte f?rstadiet till en infarkt, sk instabil k?rlkramp. I samma studie gjorde vi en separat analys p? patienter ?ver 75 ?r och s?g d? att f?rh?jda koncentrationer av hsTnT var mycket vanligt hos ?ldre patienter. Det var s? vanligt att majoriteten av de patienter som hade f?rh?jda v?rden inte hade n?gon hj?rtinfarkt. Med anledning av detta fynd gjorde vi en f?rdjupad studie av de ?ldre patienterna d?r vi f?rs?kte optimera diagnostiken med hsTnT p? olika s?tt. Vi analyserade bla om ett h?gre tr?skelv?rde kunde minska andelen patienter som felaktigt definierades som sjuka utan att missa n?gon patient med instabil kransk?rlssjukdom. Det visade sig att till?tandet av ett h?gre tr?skelv?rde riskerade att missa patienter med en p?g?ende hj?rtinfarkt. Vi provade d? att kombinera ett h?gre ankomstv?rde med olika niv?er av koncentrationsf?r?ndringar mellan ankomst till sjukhus och efter tre timmars observationstid. Denna strategi minskade andelen friska patienter som felaktigt definierades som sjuka men fortfarande var denna andel betydande vilket medf?rde avsev?rda sv?righeter att korrekt diagnostisera en hj?rtinfarkt hos ?ldre patienter. F?r att se om vi ytterligare kunde f?rkorta observationstiden p? akutmottagningen analyserade vi en metod som kombinerade provtagning f?r hsTnT med copeptin i samband med ankomst till sjukhus. Copeptin ?r ett hormon som fris?tts fr?n hypofysen i samband med att kroppen uts?tts f?r n?gon form av stress. ?terigen fann vi att det gick utm?rkt att utesluta en manifest hj?rtinfarkt men inte f?rstadiet instabil k?rlkramp. Att analysera hsTnT tillsammans med copeptin vid ankomst visade sig vara lika bra som enbart hsTnT efter tre timmar f?r att utesluta hj?rtinfarkt. Nackdelen var att det blev en ?nnu st?rre andel friska patienter som felaktigt definierades som sjuka. Eftersom det inte gick att s?kert identifiera alla patienter med instabil kransk?rlssjukdom enbart med hj?lp av blodprov, unders?kte vi om en enkel analys av riskfaktorer f?r hj?rtinfarkt i kombination med hsTnT kunde anv?ndas f?r att f?nga alla patienter med instabil kransk?rlssjukdom Vi kallade v?rt beslutst?d f?r CORE (The Clinical Objective Rule-out Evaluation). Med hj?lp av detta beslutsst?d blev risken att missa en patient med allvarlig hj?rtsjukdom mindre ?n en procent. Sammanfattningsvis ?r det sv?rt att med hj?lp av hsTnT och copeptin s?kert p?visa en hj?rtinfarkt. Inom detta omr?de kr?vs ytterligare forskning. D?remot visar avhandlingen att s?v?l hsTnT som copeptin ?r effektiva verktyg f?r att tidigt kunna utesluta akut hj?rtinfarkt. Med hj?lp av beslutsst?det CORE kan ?ven instabil k?rlkramp uteslutas och detta kan m?jligg?ra f?rkortad vistelsetid p? akutmottagningen, minskat lidande f?r patienter och ett mer effektivt resursutnyttjande. 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