RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE ...



"A STUDY OF ELECTROCARDIOGRAPHIC AND 2D ECHOCARDIOGRAPHY CORRELATION IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY"

SYNOPSIS OF DISSERTATION SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

In partial fulfillment of regulations for the award of

M.D. Degree in General Medicine

Submitted by

Dr. JAGADEESH.S.G. M.B.B.S.

POST GRADUATE STUDENT IN

GENERAL MEDICINE (M.D.)

Under the guidance of

Dr. VIMALA .S. IYENGAR . M.B.B.S., M.D.,

ASSOCIATE PROFESSOR,

DEPARTMENT OF GENERAL MEDICINE,

A.I.M.S., B.G.NAGARA-571448.

DEPARTMENT OF GENERAL MEDICINE

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

2011

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

|1 |NAME OF THE CANDIDATE |Dr JAGADEESH. S.G. |

| |AND ADDRESS |P.G. IN GENERAL MEDICINE, |

| |(in block letters) |A.I.M.S., B.G. NAGARA, |

| | |MANDYA DISTRICT -571448 |

|2. |NAME OF THE INSTITUTION |ADICHUNCHANAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES, B.G.NAGARA. |

|3. |COURSE OF STUDY AND SUBJECT |M.D. IN GENERAL MEDICINE |

|4. |DATE OF ADMISSION TO COURSE |15st JUNE 2011 |

| | |“STUDY OF ELECTROCARDIOGRAPHIC AND 2D ECHOCARDIOGRAPHY CORRELATION IN |

|5. |TITLE OF THE TOPIC |PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY.” |

| | | |

|6. |BRIEF RESUME OF INTENDED WORK |APPENDIX-I |

| |NEED FOR THE STUDY |APPENDIX-IA |

| |6.2 REVIEW OF LITERATURE |APPENDIX-IB |

| |6.3 OBJECTIVES OF THE STUDYs |APPENDIX-IC |

| | | |

|7 |MATERIALS AND METHODS |APPENDIX-II |

| | | |

| |SOURCE OF DATA |APPENDIX-IIA |

| | | |

| |7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF | |

| |ANY) |APPENDIX-IIB |

| | | |

| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE | |

| |CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE | |

| |BRIEFLY. |YES |

| | |APPENDIX-IIC |

| |7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE| |

| |OF 7.3 | |

| | | |

| | |YES |

| | |APPENDIX-IID |

|8. |LIST OF REFERENCES | APPENDIX - III |

| | | |

|9. |SIGNATURE OF THE CANDIDATE | |

| | | |

| | |RECOMMENDED |

|10. |REMARKS OF THE GUIDE | |

| | | |

|11. |11.1 NAME OF THE GUIDE |Dr. VIMALA. S. IYENGAR. M.B.B.S, M.D. |

| | |ASSOCIATE PROFESSOR, |

| | |DEPARTMENT OF GENERAL MEDICINE, |

| | |A.I.M.S, B.G.NAGARA. |

| | | |

| |11.2 SIGNATURE OF THE GUIDE | |

| | | |

| | | |

| | | |

| | | |

| | | |

| |11.3 CO-GUIDE (IF ANY) |- |

| |11.4 SIGNATURE |- |

| | | |

| |11.5 HEAD OF DEPARTMENT |Dr. MOHAN. M.E M.B.B.S., M.D. |

| | |PROFESSOR & HEAD, |

| | |DEPARTMENT OF GENERAL MEDICINE, |

| | |A.I.M.S, B.G.NAGARA. |

| | | |

| |11.6 SIGNATURE | |

| | | |

| | | |

| | | |

| | | |

| | | |

|12 |12.1 REMARKS OF THE CHAIRMAN |The facilities required for the investigation will be made available by |

| |AND PRINCIPAL |the college |

| | | |

| | |Dr. M.G. SHIVARAMU, M.B.B.S, M.D. |

| | |PRINCIPAL, |

| | |AIMS, B.G. NAGARA. |

| | | |

| |12.2 SIGNATURE | |

| | | |

| | | |

| | | |

APPENDIX-I

6.BRIEF RESUME OF THE INTENDED WORK:

APPENDIX –I A

6.1 NEED FOR THE STUDY:

Left ventricular hypertrophy is no longer considered as an adaptive mechanism that compensates the pressure imposed on the heart and has been identified as an independent and significant risk factor for sudden death, acute myocardial infarction, congestive cardiac failure, and stroke.1

Framingham heart study reveals that 1 in 10 individuals will have left ventricular hypertrophy in the age group of 65-69 years.2

Studies clarify strong relationship between left ventricular hypertrophy and adverse outcome and hence emphasize on the clinical importance for its detection.3

Electrocardiography in the assessment of cardiac dimension has lost its prominence in favour of imaging techniques like echocardiography but ST-Tchanges due to LVH. Which are uniquely determined from the electrocardiography are know to increase the risk of cardiovascular morbidity and mortality.4

The increase in left ventricular mass represents a final pathway towards the adverse impact on cardiovascular system and higher vulnerability to complication.5

Left ventricular hypertrophy imposes a great cardiovascular risk, whether it is diagnosed by electrocardiography or 2D echocardiography. However, both these methods for detecting left ventricular hypertrophy have drawbacks. The electrocardiography is rather insensitive in detecting anatomical left ventricular hypertrophy however 2D echocardiography is more expensive and less available widely, considerably more time, cost, technical skill of the operator and complexity of processing than routine 12 lead electrocardiography.

This study is done to compare between electrocardiographic criteria’s for left ventricular hypertrophy, using echocardiography as standard.

APPENDIX –I B

1. REVIEW OF LITERATURE

• Left ventricular hypertrophy is defined as an increase in muscle mass of the left ventricle.6

• Hypertension, obesity, advanced age, valvular heart disease and other pathological disorders that cause an increase the hemodynamic burden can lead to LVH.

• LVH has been proven to be an extremely useful predictor of prognosis, regardless of whether it occurs in hypertensive patients or in the general population.

• Prevalence of left ventricular hypertrophy according to Framingham heart study is 1 in 10 in the age group of 65-69 years. 2

ELECTOCARDIGRAPHIC CRITERIA FOR LEFT VENTRICULAR HYPERTROPHY

Romhilt –esters scoring system for left ventricular hypertrophy.7

1. 1 .R or S wave in any limb ≥ 2 mv 3

or S in V1 lead or V2

or R in lad V5 or V6 ≥ 3 mv

left ventricular strain

2. ST segment and T wave in opposite direction to QRS complex

Without digitalis 3

With digitalis 1

3. Left atrial enlargement 3

Terminal negativity of P wave in lead V1 is ≥0.10 mv in depth

and ≥0.04s in duration

4. Left axis deviation ≥ 30 degree 2

5. QRS duration ≥0.09s 1

6. Intrinsicoid detection in lead V5 or V6 ≥ 0.05s 1

Maximum score 13

Definite left ventricular hypertrophy -5 or more points

Left ventricular hypertrophy, probably – 4 points

Sokolow – lyon criteria for left ventricular hypertrophy.8

S wave in lead V1 plus R wave in lead in V5 or V6 ≥ 3.5 mv

or

R wave in lead V5 or V6 ≥ 2.6 mv

Cornell voltage criteria for left ventricular hypertrophy.9

Female - R wave in lead AVL plus S wave in V3 ≥ 2.00mv

Male - R wave in lead AVL plus S wave in V3 ≥ 2.8mv

• Better quantification of LVH was obtained by estimating left ventricular mass , first derived from M- mode ECHO by various groups in the early 1970s .This is done by estimating the volume of LV myocardial “Shell”, which is the difference between the external volume of left ventricle and left ventricular chamber volume .LV mass obtained by multiplying the estimated LV myocardial volume by 1.04, the specific gravity of myocardium .Formulas such as that of Troy et al, were used widely in early LV mass studies, but not validated by anatomic correlation.

• Devereux and Reicheck.10 were first to correlate echocardiography LV mass estimates with LV specimen of the same heart at autopsy. They tested various geometric formulas and different methods of measuring wall thickness and LVID and found that anatomic LV mass correlated best with LV measurements {penn convention (r=0.96)} using the following empirical equqtion:

LVM =1.04[(IVST+LVID+PWT) 3 – (LVID) 3 ] -13.6g

Where LVID - left ventricular diameter during diastole.

LVPWT - left ventricular posterior wall thickness in diastole.

IVST - interventricular septal thickness in diastole.

• Using American society of echocardiography (ASE) method of measuring septal and left ventricular wall thickness, Devereux and Woytholer et al., found a good correlation between ECHO and anatomic LV mass (r=0.9 and 0.81 respectively)11 r-correlation

CRITERIA FOR LVH BY ECHOCARDIOGRAPHY 12

LV mass: Male > 115 g/m2

Female > 95 g/m2

LV posterior wall thickness ( Diastole ) : Male > 10 mm

Female > 9 mm

APPENDIX –IC

AIMS AND OBJECTIVES.

• To identify the left ventricular hypertrophy.

• Comparison of relative sensitivity, and specificity of echocardiography and 12 lead ECG for detecting left ventricular hypertrophy.

• Designed to assess the role of selected electrocardiographic criteria of left ventricular hypertrophy, using echocardiography as diagnostic standard in 100 consecutive cases.

APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-IIA

7.1 SOURCE OF DATA:

The subjects will be recruited from patients attending medical OPD, in-patients , including ICU and cases referred for pre-op evaluation at Adichunchanagiri Hospital and Research Centre, B.G.Nagara, Mandya .

STUDY PERIOD : 18 months, from Janaury 2012 to August 2013.

STUDY DESIGN – Cross sectional study

Sample size = 100

APPENDIX-IIB

1. METHOD OF COLLECTION OF DATA

INCLUSION CRITERIA

• Evidence of concentric LVH by echocardiographic criteria 7 ,8,9 and / or evidence of LVH by electrocardiographic criteria 12

• Selected patients will be studying in detail with history and physical examination.

History:

• Age, Sex, Duration of illness.

• Presenting symptoms.

• Past history of any illness.

• Any history of drug intake , if yes regularity of duration of treatment.

• Personal history: Smoking ,Alcohol consumption, diet.

Examination:

• Pulse, Blood pressure.

• Relevant Cardiovascular findings.

Investigation:

• Electrocardiography

• 2Dechocardiography

• Chest X ray

• Complete hemogram, RBS, Blood urea, serum creatinine , Urine examination, Lipid profile,

• Ultra sound in relevant cases

Statistical Tests:

1. Proportions (Specificity, Sensitivity, positive predictive value, Likely hood ratio)

2. Kappa measurement of agreement

3. Mc-Neimer’s Chi –square test.

APPENDIX-II C

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so describe briefly?

YES

INVESTIGATIONS :

• Routine investigations:

o Haemoglobin percentage

o Total count

o Differential count

o Erythrocyte sedimentation rate

o Urine for protein, sugar and microscopy

o Random blood sugar, Lipid profile

o Blood urea

o Serum creatinine.

• Specific investigations:

o Chest radiograph

o Electrocardiography

o 2D Echo

o Ultrasound abdomen

APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

| |SECTION A | |

|A |Title of the study |“STUDY OF ELECTROCARDIOGRAPHIC AND 2D ECHOCARDIOGRAPHY CORRELATION IN |

| | |PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY” |

|B |Principle investigator | |

| |(Name and Designation) |Dr JAGADEESH. S.G. |

| | |P.G. IN GENERAL MEDICINE, |

| | |A.I.M.S., B.G. NAGARA, |

| | |MANDYA DISTRICT –571448 |

|C |Co-investigator | |

| |(Name and Designation) |Dr. VIMALA. S. IYENGAR. M.B.B.S, M.D. |

| | |ASSOCIATE PROFESSOR, |

| | |DEPARTMENT OF GENERAL MEDICINE, |

| | |A.I.M.S, B.G.NAGARA. |

|D |Name of the Collaborating |NA |

| |Department/Institutions | |

|E |Whether permission has been obtained from the heads of the |NA |

| |collaborating departments & Institution | |

| |Section – B |APPENDIX I |

| |Summary of the Project | |

| |Section – C |APPENDIX IC |

| |Objectives of the study | |

| |Section – D |APPENDIX IIB |

| |Methodology | |

|A |Where the proposed study will be undertaken |ADICHUNCHANAGIRI HOSPITAL AND RESEARCH CENTRE, B.G.NAGARA |

|B |Duration of the Project |18 MONTHS |

|C |Nature of the subjects: | |

| |Does the study involve adult patients? |YES |

| |Does the study involve Children? |NO |

| |Does the study involve normal volunteers? |NO |

| |Does the study involve Psychiatric patients? |NO |

| |Does the study involve pregnant women? |NO |

|D |If the study involves health volunteers | |

| |Will they be institute students? |NO |

| |Will they be institute employees? |NO |

| |Will they be Paid? |NO |

| |If they are to be paid, how much per session? |NA |

|E |Is the study a part of multi central trial? |NO |

|F |If yes, who is the coordinator? | |

| |(Name and Designation) |NA |

| | | |

| |Has the trial been approved by the ethics Committee of the other |NA |

| |centers? | |

| | | |

| |If the study involves the use of drugs please indicate whether. |NA |

| | | |

| |I. The drug is marketed in India for the indication in which it will | |

| |be used in the study. |NA |

| | | |

| |II. The drug is marketed in India but not for the indication in | |

| |which it will be used in the study | |

| | |NA |

| |III. The drug is only used for experimental use in humans. | |

| | | |

| |IV. Clearance of the drugs controller of India has been obtained for:| |

| | |NA |

| | | |

| |Use of the drug in healthy volunteers | |

| |Use of the drug in-patients for a new indication. |NA |

| |Phase one and two clinical trials | |

| |Experimental use in-patients and healthy volunteers. | |

| | | |

| | |NA |

|G |How do you propose to obtain the drug to be used in the study? |NA |

| |Gift from a drug company | |

| |Hospital supplies | |

| |Patients will be asked to purchase | |

| |Other sources (Explain) | |

|H |Funding (If any) for the project please state |NA |

| |None | |

| |Amount | |

| |Source | |

| |To whom payable | |

|I |Does any agency have a vested interest in the out come of the Project? |NO |

|J |Will data relating to subjects /controls be stored in a computer? |NO |

|K | Will the data analysis be done by | |

| |The researcher? |YES |

| |The funding agent |NO |

|L |Will technical / nursing help be required form the staff of hospital. | |

| | |NO |

| |If yes, will it interfere with their duties? | |

| | | |

| |Will you recruit other staff for the duration of the study? | |

| | |NO |

| |If Yes give details of | |

| |Designation |NO |

| |Qualification | |

| |Number | |

| |Duration of Employment |NA |

| | |NA |

| | |NA |

| | |NA |

| | |NA |

|M |Will informed consent be taken? If yes |NO |

| |Will it be written informed consent: |NA |

| |Will it be oral consent? Will it be|NA |

| |taken from the subject themselves? |NA |

| |Will it be from the legal guardian? If no, give reason: |NA |

|N |Describe design, Methodology and techniques |APPENDIX II |

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date :

PS : NA – Not Applicable

APPENDIX - III

LIST OF REFERENCES:

1. Devereux RB. “Does increased blood pressure cause left ventricular hypertrophy or vice versa.” Annals of internal medicine, 2000; 112:57-8

2. Friedman AJ et al., “Accuracy of M –mode echocardiographic measurements of left ventricle.” A m J Cardiol 1982; 99: 716-720.

3. Vakili B.A., Okin P. M., Devereux R.B ., “Prognostic implication of left ventricular hypertrophy .” Am Heart Journal, 2001; 141:334-341

4. Elena Martinova. et al ., Automated Computer Analysis in Diagnosis of Left ventricular hypertrophy by electrocardiography. Journal of Electrocardiography, 2007; 40: S41-S42.

5. Devereux RB, Reicheck MD. “Echocardiographic determination of left ventricular mass in men ; Anatomic validation of method ”Circulation 1997;55:613-8

6. Denarie N., et . al., “Utility of electrocardiogram for predicting increased left ventricular mass in asymptamatic men at risk for cardiovascular disease.”Am J Hypertension, 1998; 11:861-865.

7. Modified from Romhilt DW, Bove KE, Norris RJ, et al. A critical appraisal of the electrocardiographic criteria for the diagnosis of left ventricular hypertrophy. Circulation 1969; 40: 185.

8. Modified from Sokolow M, Lyon TP. “The ventricular complex in left ventricular hypertrophy as obtained by unipolar precordial and limb leads” Am Heart J 1949; 37:161

9. Modified from Casalo PN , Devereux RB,Alonso DR, et al. Improved Sex specific criteria of left ventricular hypertrophy for clinical and computer interpretation of electrocardiogram: Validation with autopsy findings.Circulaon 1987; 75-565.

10. Devereux R B, Alono D R, Lutas EM, etal. Echocardiographic assessment of left ventricular hypertrophy ; Comparison to necroscopy finding . AmJ Cardiol 1986; 57 : 450-458

11. Devereux R .B., “Detection of Left ventricular hypertrophy by M –mode Echocardiography.” Hypertension 1987;9:19-23.

12. Lang RM, Bierig M, Devereux RB, et al., :Recommendations for chamber Quantification: A report from the American Society of Echocardiography’s Guidelines and standard committee and the chamber Quantifications Writing Group , developed in conjunction with the European Association of Echocardiography , branch of the European Society of Cardiology, J Am Soc Echocardiogr 18:1440,2005

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