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RAJIV GANDI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.

NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS)

2.

NAME OF THE INSTITUTION

3.

COURSE OF STUDY AND SUBJECT DATE OF ADMISSION TO COURSE AND DATE OF COMMENCEMENT OF COURSE

M.D (MEDICINE)

TITLE OF TOPIC

STUDY OF ASSOCIATION OF CREACTIVE PROTEIN AND LDL-HDL CHOLESTEROL RATIO IN ACUTE MYOCARDIAL INFARCTION

4.

5.

DR. JAGADISH NAYAK POST-GRADUATE IN GENERAL MEDICINE, DEPARTMENT OF MEDICINE, MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE-570001 MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE MYSORE

14-06-2011 24-06-2011

1

6. BREIF RESUME OF THE INTENDED WORK

6.1 Need for the study –

Acute myocardial infarction triggers an inflammatory reaction which plays an important role in myocardial injury . inflammatory markers such as c-reactive protein reflect the extent of myocardial necrosis and correlate with cardiac outcomes following acute myocardial infarction . Recent research has focused on the use of high-sensitivity C-reactive protein (hs-CRP), a marker of inflammation, in the detection of patients at increased risk for cardiovascular disease. Several prospective studies have demonstrated that hs-CRP is an independent predictor of future risk for cardiovascular events among healthy individuals, as well as among patients with acute coronary syndromes. In addition, because half of all cardiovascular events occur in persons with low to average levels of low-density lipoprotein cholesterol, hs-CRP may aid in identifying patients at high risk for a first cardiovascular event who might otherwise be missed by lipid screening alone. Thus, hs-CRP is a potential adjunct for global risk assessment in the primary prevention of cardiovascular disease A more tenable option that has been proven to be an accurate predictor of cardiovascular risk is the LDL-C/ HDL-C ratio which can be obtained from a standard lipid profile and is more accurate than LDL-C or HDL-C alone. The present study was conducted to study the association of serum CRP levels and LDL:HDL ratio in the patients

2

6.2 Review of Literature

1. case control study was conducted at National Institute for Cardiovascular Disease (NICVD). In this study, CRP levels were significantly high and serum HDL levels significantly low in patients as compared to controls. Serum LDL levels and the ratio of LDL and HDL were not significantly different among the two groups. 2. The Honolulu Heart Program analyzed frozen serum samples to assess the relationship of hsCRP to the development of myocardial infarction in clinically healthy men over a follow-up period of 20 years Overall, hs-CRP levels in this study were associated with coronary events that occurred as many as 15 years later 3. Elevated hs-CRP has been shown to be a strong predictor of future cardiovascular risk in patients with established CHD, with or without a previous myocardial infarction. In the Scandinavian Simvastatin Survival Study, elevated hs-CRP levels predicted mortality in patients 4.In this study, higher CRP levels in patients were associated with lower HDL, as compared to controls .Higher CRP levels were also found associated in patients with high BMI and age group 46-60 years. This study did not show significantly higher levels of LDL among patients within various groups. CRP appeared to be more strongly associated with CAD as compared to serum HDL, LDL-cholesterol or their ratio in all groups.with stable ischemic heart disease 5. Low HDL is shown to be associated with higher prevalence and incidence of CAD. This study also had similar observations with majority of patients having LDL:HDL >3. Low HDL in

individuals in age group 46-60years, was also associated with greater

prevalence of AMI

3

6.In PROCAM study it was found that a continous and graded relationship between the LDL-C /HDL-C ratio and cvd mortality coronary deaths spiked when the LDL-HDL ratio reached between 3.7 and 4.3.

7. The use of hs-CRP as an adjunct to lipid screening in primary prevention is intended to improve global risk prediction in patients not clearly identified as being at high risk by cholesterol levels alone 8. Using widely available high sensitivity assays CRP levels of <1 ,1-3, >3 mg/l corresponds to low , moderate and high risk groups for cardiovascular events .

6.3 Objectives of Study.

To determine the association of high serum CRP levels and LDL:HDL in the patients presenting with acute myocardial infarction.

7.MATERIALS AND METHODS

7.1 Source of Data Patients with acute myocardial infarction who fulfill inclusion and exclusion criteria , getting admitted to K R hospital mysore during the period of December 2011 to August 2013.

7.2 Method Of Collection of Data Sample size: 100 Sampling Method: 4

Simple random sampling 7.3 Inclusion Criteria: 1. Age >40 years 2. Acute myocardial infarction evidenced by ECG, Elevated Troponin T ,2D Echocardiography

7.4 Exclusion Criteria: 1.Patients below 40years of age 2 .Individuals with rheumatic disease,chronic liver diseases,renal disorders,cancer,sepsis and patient critically ill with less than one month duration infectious diseases and surgical procedure in 3 month duration. 3 .patient on statin therapy. 7.5 Method of study: Data will be collected using a pretested proforma meeting the objectives of the study. Detailed history and necessary investigations will be undertaken. The purpose of the study will be explained to the patient and informed consent obtained. The patients included were diagnosed as acute myocardial infarction on the basis of history, clinical examination, ECG, and laboratory investigations. The controls were age, sex and socioeconomically matched persons not having any heart disease. The participants were excluded if they had a past history of any heart disease, diabetes mellitus, any infection or inflammatory disease. The study included the quantitative estimation of serum C-Reactive Protein (CRP), Low-density Lipoproteins (LDL), High-density Lipoproteins (HDL), Fasting Blood Sugar (FBS) as well as Complete Blood Count (CBC) . 5

The analysis of the Data will be done using appropriate statistical method .Ethical committee will be taken

7.6 INVESTIGATIONS 1. 2. 3. 4. 5. 6. 7.

ECG TROP T,CK MB CRP LIPID PROFILE[LDL-C,HDL-C AND LDL-C/HDL-C RATIO] BLOOD GLUCOSE LEVEL COMPLETE BLOOD COUNT 2D ECHOCARDIOGRAPHY

7.4 Has ethical clearance been obtained from your institution : Yes [copy enclosed]

8. REFERNCES: 1. Sakkinen P, Abbott RD, Curb JD, Rodriguez BL, Yano K, Tracy RP. C-reactive protein and myocardial infarction. J Clin Epidemiol. 2002;55:445-451 6

2. Cesari M, Penninx BW, Newman AB, Kritchevsky SB, Nicklas BJ, SuttonTyrrell K, et al. Inflammatory Markers and Onset of Cardiovascular Events: Results from the Health ABC Study. Circulation 2003;108:2317-22. 3. Crea F, Monaco C, Lanza GA, Maggi E, Ginnetti F, Cianflone D, et al. Inflammatory predictors

of

mortality

in

the

Scandinavian

Simvastatin

Survival

Study.

Clin

Cardiol.2002;25:461-466 4.Pearson TA, Mensah GA, Hong Y, Smith SC Jr, for the Centers for Disease Control and Prevention and the American Heart Association Workshop on Markers of Inflammation and Cardiovascular Disease. CDC/AHA workshop on markers of inflammation and cardiovascular disease: application to clinical and public health practice: overview. Circulation.2004; 110:e543544 5. Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention [review]. Circulation.2003;107:363-369 6.bibi kulsoom , s nazral hasnain . department of biochemistry ,ziauddin medical university and hospital Karachi. Association of serum c reactive protein and ldl/hdl ratio in MI. 7. Cullen p . Schulte ,H.Assmann G ; The munster heart study (PROCAM) Total mortality in middle aged men is increased at low total and ldl cholesterol concentrations in smokers but not in non smokers circulation .96;2128-2136,1997. 8 Rader J. Daniel, Hobbs. H Helen. Disorders of lipoprotein metabolism. Harrison’s Principles of Internal Medicine 18th edition. Pg no. 3157-3159.

7

9.SIGNATUE OF THE CANDIATE:

Dr. JAGADISH NAYAK

10. REMARKS OF THE GUIDE:

11.NAME AND DESIGNATION OF 11.1 Guide:

Dr. MOHAMMED GHOUSE SHARIFF MD

PROFESSOR DEPARTMENT OF MEDICINE, MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE

11.2 SIGNATURE:

11.3 HEAD OF THE DEPARTMENT:

Dr .H VASUDEVA NAIK MD

PROFESSOR AND HEAD DEPARTMENT OF MEDICINE MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE 11.4 SIGNATURE:

12 12.1 REMARKS OF DEAN AND DIRECTOR: 12.2 SIGNATURE: 8

ETHICAL COMMITTE CLEARENCE

1. TITLE OF DISSERTATION:

STUDY OF ASSOCIATION OF CRP AND LDL-C /HDL-C RATIO IN MYOCARDIAL INFACTION PATIENTS

2.NAME OF THE CANDIDATE:

DR. JAGADISH NAYAK

3.SUBJECT:

MD GENERAL MEDICINE

4.NAME OF THE GUIDE:

DR. MOHAMMED GHOUSE SHARIFF MD

PROFESSOR DEPT OF MEDICINE, K R HOSPITAL MMC&RI, MYSORE

5.APPROVED/NOT APPROVED: APPROVED [If not approved ,suggestions]

9

MEMBERS OF ETHICAL CLEARANCE COMMITTEE

PROFESSOR AND HOD DEPT OF MEDICINE MMC&RI,MYSORE

PROFESSOR AND HOD DEPT OF SURGERY MMC&RI, MYSORE

MEDICAL SUPERINTENDENT K R HOSPITAL MYSORE

MEDICAL SUPERINTENDENT CHELUVAMBA HOSPITAL MYSORE

SUPERINTENDENT PKTB HOSPITAL MYSORE

LAW EXPERT

DIRECTOR AND DEAN, MMC&RI, MYSORE

From, Dr. JAGADISH NAYAK Post-graduate in General Medicine Department of General Medicine 10

Mysore Medical College & Research Institute Mysore. To, Registrar (Evaluation) Rajiv Gandhi University of Health Sciences Bangalore. Through proper channel. Respected Sir, Subject: Submission of Synopsis titled “STUDY OF ASSOCIATION OF C-

REACTIVE PROTEIN AND LDL-HDL CHOLESTEROL RATIO IN ACUTE MYOCARDIAL INFARCTION” I am hereby submitting the above titled synopsis (4 copies) as mentioned above, so kindly accept my application and do the needful. Thanking you, Yours faithfully, (DR.JAGADISH NAYAK) Forwarded to Dean and Director, MMC & RI, Mysore for further needful action.

Professor and Head, Department of Gen. Medicine MMC & RI, Mysore

Date: Place:

11

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