RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

ANNEXURE-II

|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

|TO BE SUBMITTED IN DUPLICATE |

| | | |

|1. |NAME OF THE CANDIDATE AND ADDRESS |DR.NIMISHA V |

| | |‘DEEPAM’; PO:DHARMADAM |

| | |TELLICHERRY |

| |ADDRESS FOR |KERALA 670106 |

| |CORRESPONDANCE | |

| | |DR. NIMISHA V |

| | |PG IN BIOCHEMISTRY |

| | |DEPT OF BIOCHEMISTRY |

| | |MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401. |

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|2. |NAME OF THE INSTITUTION |MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401. |

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|3. |COURSE OF THE STUDY AND SUBJECT |M.D. BIOCHEMISTRY |

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|4. |DATE OF ADMISSION TO THE COURSE |16-05-2012 |

| | |A CROSS SECTIONAL STUDY TO CORRELATE BIOCHEMICAL PARAMETERS WITH RISK FACTORS OF |

|5. |TITLE OF THE TOPIC |CORONARY HEART DISEASE IN MANDYA CITY. |

6. Brief resume of intended work.

6.1. Introduction and need for the study:

Cardiovascular diseases, diabetes mellitus, cancers, chronic obstructive lung disorders and injuries are major Non Communicable Diseases (NCDs) in South East Asia region (SEAR) according to World Health Organization.1 The world health report 2001 states that NCDs account for almost 60% of deaths and 46% of global burden of diseases.1

It is now seen that cardiovascular diseases (CVDs) are major contributors to global burden of chronic diseases with 29.3% of global deaths and 9.9 % of total disease burden, in terms of disability adjusted life years .2 Cardiovascular diseases are a group of disorders of heart and blood vessels which includes- Coronary heart disease (syn. ischemic heart disease), Cerebrovascular disease, Peripheral vascular disease, Rheumatic Heart Disease, Congenital Heart Disease, Deep Vein Thrombosis and Pulmonary Embolism.3

Cardiovascular diseases are responsible for about 25% of the DALYs lost due to non communicable diseases in SEAR countries. Of this coronary heart disease (CHD) account for 40% of DALYs lost, cerebrovascular diseases about 19%, Rheumatic Heart Disease 6%, inflammatory heart disease about 6% and other conditions about 29%.4

A study conducted by WHO(1998-2000) using clinical history and ECG changes as parameters, estimated the prevalence of CHD as 9.67 % in urban areas and 27.1% in rural areas.5

Similar to communicable diseases, where there is a disease agent that can be targeted to treat the patient, in non communicable diseases what can be targeted are the risk factors which eventually lead to the disease. ‘Risk’ is defined as a probability of an adverse health outcome, whereas ‘risk factor’ refers to an attribute or characteristic or exposure of an individual whose presence or absence raises the probability of an adverse outcome.6

Many factors like demographic and health transitions, gene-environment interaction and early life influences of foetal malnutrition are causes of increasing CVD burden7 and hence CHD burden in India. However the changes in living habits are also important, which transform behavioural risk factors into biological risk factors.7 Risk factors including tobacco, alcohol use, lack of physical activity, obesity, stress which further lead to overweight, obesity, hypertension and hypercholesterolemia, contribute to development of non communicable diseases.8 Behavioural risk factors are responsible for 80% of CHD and cerebrovascular diseases and out of 32 million individuals who develop these every year, majority have one or more of these risk factors. Hence, if corrective actions are taken against risk factors, this can be prevented.9

. India has earned the fame of being the Diabetes capital and is on the verge of being called Hypertension capital in a few years from now.10The present study is based on a three STEP approach recommended by The World Health Organization for NCD Risk factor surveillance

STEP 1. Gather information through questionnaire

STEP 2. Ascertain simple physical measurements and

STEP 3. Collect blood samples.11

Prevalence of biochemical risk factors along with relation between them and other risk factors which includes sociodemographic data like age, gender, per capita income, behavioural risk factors like smoking, alcoholism and physical risk factors related to high Body Mass Index (BMI), waist circumference, hypertension will be studied. It is seen that due to limited resources and technical support, STEP 3 is usually difficult to carry out in a large scale in low and middle income group countries. So, available resources should be utilized in such a way that, all districts have each and every person in their area, under their health scanner, which keeps a check on risk factors and diseases.

NCD risk-factor surveys using the STEPS approach were carried out in some parts of India and it was found that proportion (%) with raised fasting blood sugar and blood cholesterol was 10.9% and 33.2% respectively in urban population. Also, percentage of smokers and alcohol consumers was 15.7% and 20.7% respectively in the same population. 12

There are many biochemical alterations that occur in a person suffering from diabetes, hypertension or hypercholesterolemia. The risk factors are interrelated to each other. For example, smoking causes reduction in High Density Lipoprotein (HDL) cholesterol13. Chronic cigarette smoking makes (Low Density Lipoprotein) LDL cholesterol more atherogenic.14 Alcohol consumption causes hypertriglyceridemia which is an important risk factor for coronary heart disease.15 In a diabetic, elevated triglycerides due to alcohol consumption, interferes with insulin production by causing pancreatitis, hence worsening the diabetes status.15 High serum cholesterol is associated with an impaired vasodilatory capacity and an over expression of vascular angiotensin II receptors which can cause hypertension.16 Also, chronic cigarette smoking seems to aggravate insulin resistance in patients with non insulin dependent diabetes mellitus.17

Hence the need for this study is to determine the prevalence of biochemical risk factors of CHD and to correlate it with other risk factors which will help in understanding the concept of risk factors to disease progression better.

The data obtained, can also be used to fill the information gap, regarding altered biochemical parameters in CHD risk factors surveillance in Mandya city.

6.2. Review of literature:

According to Mark D Huffman’s report on Coronary Heart Disease in India, CHD is the leading cause of death in India(WHO,2004;WHO,2009). It is seen that it affects people at younger age group in low and middle income countries, thereby having a greater economic impact on those countries.18

An epidemiological survey of diabetes mellitus was conducted between November 1985 and June 1986 in Taiwan by Tong- Yuan Tai et al to deduce the link between hypertension and diabetes and it was found that prevalence of diabetes significantly increased as mean arterial pressure increased.19

Murray CJL, Lopez AD in their article state that cardiovascular diseases have assumed epidemic proportions in India and the Global Burden of Diseases (GBD) study reported the estimated mortality from ischemic heart disease in India at 6.3 million in the year 1990.20

In a study conducted in Ireland from 1985-2000 by Bennett K et al, a 4.6% reduction in the population mean of total cholesterol level had the greatest impact of all risk factors in decreasing coronary heart disease mortality.21

WHO profile about Non communicable diseases in South East Asia Region (2002) states that except for Thailand and Indonesia, none of the countries have a systematic collection of risk factor data.1

According to a community based study done by K.R. Thangappan et al in Kerala in 2005-06, prevalence of behavioral and biochemical risk factors increases with age. It is suggested in the same study that anthropometric measurements alone, without biochemical measurements may not be of much use for population screening methods. Also, women had higher odds of overweight, obesity and hypercholesterolemia but lower odds of having hypertension, low HDL or hypertriglyceridemia.22

Sociodemographic patterning of non-communicable disease risk factors in rural India was studied cross sectionally by Sanjay Kinra et al from march 2005 to dec 2007, and it was found that tobacco and alcohol use, low intake of fruits and vegetables, and underweight were more common in lower socioeconomic position whereas obesity, dyslipidemia and diabetes (men only) and hypertension (women only) were more prevalent in higher socioeconomic positions.23

According to the article, Epidemiology of Cardiovascular diseases in Type 2 Diabetes: The Indian Scenario, by Viswanathan Mohan et al(2010) , diabetics have a two to four times increased risk of CHD, and CHD has been reported to occur earlier in diabetics than non-diabetics.24

Krishnan A et al (2010) studied the case of risk factors surveillance in CVD prevention and it was noted that risk factor monitoring was put into practice in US from 1984 onwards. The STEPS approach was developed by WHO, in 2003, as a global tool against NCD risk factor surveillance. Government of India initiated risk factor surveillance as a part of National Integrated surveillance programme in 2007. The delay between evidence and programme has been primarily due to lack of availability of standard procedures, guidelines and tools. Once a standard global tool was evolved, uptake of surveillance initiatives in India has gathered momentum.25

The paper based on Plan of Action for prevention and control of NCDs in India during the 12th plan by RK Srivastava and D Bachani(2011) refers to this point that, approximately half of the total economic burden is reported to account for by CVD including stroke, ischemic heart disease and peripheral vascular disease, which together cause more deaths than HIV\ AIDS, malaria and tuberculosis combined.8 They advice strengthening district hospitals for diagnosis and management of non communicable diseases including rehabilitation and palliative care. 8

Gupta et al(2011) stress on this point that implementation of aggressive primary prevention by keeping risk factors in check can delay occurrence of acute cardiovascular event by at least 10 years, reduce mortality burden by 25-30%, decrease utilization of tertiary care and hence help in saving money.26

6. 3. Objective of the study:

1. To determine prevalence of biochemical risk factors for CHD in Mandya city.

2. To determine correlation between biochemical parameters and sociodemographic data.

3. To determine correlation between biochemical parameters and behavioral risk factors.

4. To determine correlation between biochemical parameters and physical measurements.

7. Materials and methods:

7.1. Source of data: Population of Mandya city of age group 25- 64 yrs.

Study design: Cross sectional study

Sampling method: Stratified Random Sampling

Study area: Mandya city

Sample size: 935 randomly selected participants (prevalence of Coronary Heart Disease in urban India is 9.67%. 4)

.

7.2. Method of collection of data:

Study will be initiated after obtaining approval from the Institutional Ethics Committee of MIMS, Mandya.

935 participants will be randomly selected proportionately from 35 different ward of Mandya city. The participants will be visited in their houses in the evening. They will be explained about the study and informed consent will be taken. Questionnaire based on STEPS approach will be used for the study to assess sociodemographic and behavioural risk factors. Physical measurements which include height, weight, BMI, waist circumference, blood pressure will be recorded and he/she will be explained about fasting for 10-12 hours for the next day blood test. In order to prevent drop outs, these houses will be visited the next day morning, to draw blood sample from the participants.

These samples will be tested for the below listed biochemical parameters by various enzymatic methods- 1.Blood glucose by GOD- PAP methodology.

2. Total cholesterol by CHOD- POD methodology.

3. Serum Triglycerides by GPO Peroxidase methodology.

4. HDL by Direct determination (enzyme selective protection method).

The cut-off points used for defining abnormality are as recommended by STEPs approach.10

Participants will be informed about their results along with appropriate advice, on the same evening. The next set of houses will be visited for participant enrolment and the same procedure will be followed.

Inclusion Criteria: 1. Population of Mandya city

2. Age group 25- 64 yrs.

3. Both males and females.

Exclusion Criteria: 1.Age group 64 yr

2. Non residents of Mandya city.

3. People unwilling to enrol as participants for the study.

Statistical Analysis:

The collected data will be entered in an Excel sheet and analysed using Epi-info/SPSS software and descriptive statistics, ‘chi-square’ test, t’ test and other statistical tests will be used as applicable.

7.4. Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

Yes, physical measurements and biochemical investigations only in the enrolled participants.

Physical Measurements

Height

Weight

Body Mass Index

Waist Circumference

Blood Pressure

Biochemical Investigations

Fasting Blood Glucose

Fasting Lipid Profile

7.5. Has ethical clearance been obtained from your institution?

YES – VIDE LETTER NO: MIMS/IEC/01-05/2012-13, DATED: 20.11.2012.

8. LIST OF REFERENCES.

1. World Health Organization 2002, Non Communicable Diseases in South East Asia Region A Profile. World Health Organization regional Office for South East Asia New Delhi 2002. . accessed on 20/10/2012 10:30 hrs.

2. Reddy KS et al. Methods for establishing a surveillance system for cardiovascular diseases in Indian industrial populations. Bulletin of the World Health Organization. June 2006, 84 (6). 461-69.

3. World Health Organisation. accessed on 18/10/2012, 20:30 hrs.

4. Park K. Park’s Textbook of Preventive and Social Medicine. 21st ed. Jabalpur( India). M/s Banarsidas Bhanot. 2011. p 337.

5. WHO (2002), Health Situation in the South – East Asia Region 1998- 2000, World Health Organization. New Delhi.

6. World Health Organization. , accessed on 30/092012, 17:30 hrs

7. Bahl VK, Prabhakaran D, Karthikeyan G. Coronary artery disease in Indians. Indian Heart J 2001; 53:707-13.

8. Srivastava RK, Bachani D. Burden of NCDs, Policies & programmes for Prevention and Control of NCDs in India. Indian J of Community Med 2011; 36: 7-12.

9. WHO CVD –Risk Management package for low and medium resource settings. World Health Organization Geneva 2002.

10. Joshi .S, Parikh R. India- Diabetes Capital of the World: Now Heading Towards Hypertension [ Editorial] JAPI.vol55. May 2007.

11. World Health Organization. Geneva: WHO; STEPwise approach to surveillance (STEPS).Manual available from: accessed on 19/10/2012 2030 hrs

12. Risk factors for NCDs Results in the SEA regions. accessed on 10/10/2012: 23:00 hrs.

13. Criqui MH, Wallace RB, Heiss G, Mishkel M, Schonfeld G, Jones GT. Cigarette smoking and plasma high-density lipoprotein cholesterol. The Lipid Research Clinics Program Prevalence study. Circulation. 1980 Nov; 62(4pt2):IV70-6. accessed on 20/10/2012 1030 hrs.

14. Mahfouz MM, Hulea SA, Kummerow FA. Cigarette smoke increases cholesterol oxidation and lipid peroxidation of human low-density lipoprotein and decreases its binding to the hepatic receptor in vitro. J Environ Pathol Toxicol Oncol. 1995; 14(3-4):181-92.

15. Nicholas V. Emanuele, M.D., Terrence F. Swade, M.D., and Mary Ann Emanuele, M.D. Consequence of alcohol use in diabetics. Alcohol Health & Research World. Vol. 22, No. 3, 1998.

16. Claudio Borghi, Ada Dormi, Antonio Gaddi and Ettore Ambrosioni. P-463: Relationship between serum cholesterol and development of hypertension in the population of the Brisighella Heart Study American Journal of Hypertension 16, 207A (May 2003) | doi: 10.1016/S0895-7061(03)00635-6.

17. Giovanni Targher, Maria Alberiche, Marina B. Zenere, Riccardo C.Bonadonna, Michele Muggeo and Enzo Bonora. Cigarette Smoking and Insulin Resistance in Patients with Noninsulin-Dependent Diabetes Mellitus. J Clin Endocrinol Metab 82: 3619–3624, 1997.

18.Coronary Heart disease in India. Mark D Huffman [1].pdf accessed on 21/10/2012 1330 hrs.

19. Tong-Yuan Tai, Lee-Ming Chuang, Chien-Jen Chen, Boniface J. Lin, Link Between Hypertension and Diabetes Mellitus Epidemiological Study of Chinese Adults in Taiwan. Diabetes Care 14:1013-20, 1991.

20. Murray CJL, Lopez AD. Mortality by cause for eight regions of the world: Global burden of disease study. Lancet. 1997; 349: p1269–76.

21. Bennett K, Kabir Z, Unal B, Shelley E, Critchley J, Perry I, Feely J, Capewell S. Explaining the recent decrease in Coronary Heart Disease Mortality rates in Ireland, 1985 to 2000. J of Epidemiology Community Health. 2006 Apr; 60(4): 322-7. ncbi.nlm.pubmed/16537349 accessed on 19/10/2012 1030 hrs.

22. Thangappan K R et al . Risk factor profile for chronic non-communicable diseases: Results of a community-based study in Kerala, India. Indian J Med Res 131, January 2010, p 53-63.

23. Kinra S et al. Sociodemographic patterning of non-communicable disease risk factors in rural India: a cross sectional study BMJ 2010; 341:c4974.

24.Viswanathan Mohan, Janarthanan Vijay Venkatraman, and Rajendra Pradeepa. Epidemiology of Cardiovascular Disease in Type 2 Diabetes: The Indian Scenario. J Diabetes Sci Technol 2010; 4(1):158–170

25. Krishnan A, Yadav K, Kaur M, Kumar R. Epidemiology to public health intervention for preventing cardiovascular diseases: The role of translational Research. Indian J Med Res 132, Nov 2010, pp 643- 650

26. Gupta et al.: Translating evidence into policy for cardiovascular disease control in India. Health Research Policy and Systems 2011 9:8.

| | | |

| |SIGNATURE OF THE CANDIDATE | |

|10 | |This study to determine the prevalence of biochemical risk factors of|

| |REMARKS OF THE GUIDE |CHD would help in understanding disease progression. |

|11 |NAME AND DESIGNATION OF | |

|11.1 |GUIDE |DR. PUSHPA SARKAR |

| | |PROFESSOR & HOD |

| | |DEPARTMENTOF BIOCHEMISTRY |

| | |MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401 |

|11.2 |SIGNATURE | |

|11.3 |CO GUIDE |DR. RAGHUNATH H |

| | |ASSISTANT PROFESSOR DEPARTMENT OF BIOCHEMISTRY. |

| | |MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA-571 401 |

|11.4 |SIGNATURE | |

| | |DR. PUSHPA SARKAR |

| | |PROFESSOR & HOD |

| | |DEPARTMENTOF BIOCHEMISTRY |

|11.5 |HEAD OF THE DEPARTMENT |MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401 |

| | | |

|11.6 |SIGNATURE | |

| | |

|12 | |

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|12.1 |REMARKS OF DEAN AND PRINCIPAL | |

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|12.2 |SIGNATURE | |

WRITTEN CONSENT FORM

Subject Title: A CROSS SECTIONAL STUDY TO CORRELATE BIOCHEMICAL PARAMETERS WITH RISK FACTORS OF CORONARY HEART DISEASE IN MANDYA CITY.

Subjects Name:

Age: Gender:

i) I have been explained about the study in detail in the language I understand, and I have clarified all my doubts.

ii) I understand that my participation in the study is voluntary and that I am free to withdraw from the study at any time, without giving any reason, without my medical care or legal rights being affected.

iii) I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s)

iv) I agree to take part in the above study on my own will.

.

Signature of the subject/ left thumb impression Date

.

Signature of the witness Date

.

Signature of the investigator Date

PARTICIPANT PROFORMA

DATE: TIME:

WARD NUMBER:

HOUSE NO:

ADDRESS:

CONTACT NUMBER:

INFORMED CONSENT TAKEN(Y/N):

SOCIODEMOGRAPHIC DATA

NAME: AGE:

GENDER:

LEVEL OF EDUCATION:

PER CAPITA INCOME:

BEHAVIORAL MEASUREMENTS

1) ARE YOU A SMOKER?

IF YES, a) SINCE WHEN?

b) HOW MANY BIDIS/CIGARETTES PER DAY?

2) DO YOU CONSUME ALCOHOL?

IF YES, a) SINCE WHEN?

b) HOW OFTEN AND HOW MUCH?

3) ARE YOU A KNOWN

a) DIABETIC(Y/N) b) HYPERTENSIVE(Y/N) c) HYPERCHOLESTROLEMIC(Y/N)

IF YES FOR ONE OR MORE

| |DIABETES |HYPERTENSION |HYPERCHOLESTROLEMIA |

|a)SINCE HOW LONG | | | |

|b) IF ON TREATMENT AND SINCE WHEN? | | | |

4) ANY PREVIOUS HISTORY OF CORONARY HEART DISEASE?

IF YES a) WHEN WAS THE LAST EPISODE?

b) IF ON TREATMENT.

PHYSICAL MEASUREMENTS

1) HEIGHT( in centimetres)

2) WEIGHT(in kilograms)

3) BODY MASS INDEX(in kg/m2)

4) WAIST CIRCUMFERENCE(in centimetres)

5) BLOOD PRESSURE(in mm hg)- READING I-

READING II-

READING III (if difference of >10mm hg in either systolic or diastolic between Reading I and II)

BIOCHEMICAL MEASUREMENTS

DATE AND TIME OF BLOOD SAMPLE COLLECTION-

1) FASTING BLOOD SUGAR(in mg/dl):

2) TOTAL CHOLESTEROL (in mg/dl):

3) SERUM TRIGLYCERIDES (in mg/dl):

4) SERUM HDL CHOLESTEROL (in mg/dl):

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