Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s30

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF DISSERTATION

“A COMPARATIVE STUDY OF CAROTID INTIMOMEDIAL THICKNESS AS A SURROGATE MARKER FOR CARDIOVASCULAR EVENTS IN KVG MEDICAL COLLEGE SULLIA”

DR. SHRUNGA TEJASVI POSTGRADUATE RESIDENT, DEPARTMENT OF RADIODIAGNOSIS, KVG MEDICAL COLLEGE, SULLIA. RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE DR. SHRUNGA TEJASVI CANDIDATE AND POSTGRADUATE RESIDENT, ADDRESS DEPARTMENT OF RADIODIAGNOSIS, (IN BLOCK LETTERS) KVG MEDICAL COLLEGE, SULLIA.

2 NAME OF THE KVG MEDICAL COLLEGE, INSTITUTION KURUNJIBAG, SULLIA DAKSHINA KANNADA-574327 KARNATAKA.

3 COURSE OF STUDY M.D. RADIODIAGNOSIS AND SUBJECT

4 DATE OF ADMISSION 26/05/2012 TO COURSE

5 TITLE OF THE TOPIC A COMPARATIVE STUDY OF CAROTID INTIMOMEDIAL THICKNESS AS A SURROGATE MARKER FOR CARDIOVASCULAR EVENTS IN KVG MEDICAL COLLEGE SULLIA 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 Need for the study: Myocardial infarction (MI) remains the main cause of death in developing and developed countries, despite several prevention programmes1.

Myocardial infarction or other acute coronary syndromes are the initial symptoms of coronary artery disease in more than 50% of all patients with cardiovascular disease1. Thus, early detection of coronary artery disease may indeed provocate early effective treatment and may in turn help in reducing mortality, for example, through plaque stabilisation and more aggressive control of atherosclerotic risk factors1.

Treadmill testing and transthoracic echocardiography have limited specificity and sensitivity in diagnosing cardiovascular events in patients with atypical angina or with typical angina and negative treadmill test and echocardiography, and needs further evaluation with complementary diagnostic methods. Availability of these tests is limited while ultrasound machines are far more widely available in our country1.

Carotid intima-media thickness (IMT) has been widely used as a surrogate for atherosclerosis. Thickening of the intima-media is identified as the initial stage in the pathogenesis of atherosclerosis2.

With the help of Doppler ultrasound machines, advanced operating software, intima- media thickness (IMT) can be easily and noninvasively obtained by high-resolution transducers for better analysis of the intima-media thickness in the peripheral vessel like the carotid and femoral arteries2.

The need for this study is to determine the predictive value of intima-media thickness at 2 sites3; being common carotid artery and internal carotid artery in terms of the cardiovascular outcome events in a population consuming coconut oil for cooking in Sullia, Dakshina kannada district.

The association between hypertension, diabetes mellitus, hyperlipidaemia, cigarette smoking, age, and sex on intima-media thickness has already been well established. However, the correlation between intima-media thickness and atherosclerosis of the coronary arteries requires further investigation.1 6.2 Review of literature : A retrospective study done between November 2000 to July 2001 at Collegium Medicum Jagiellonian University, The John Paul II Hospital, Poland; concluded that IMT increases with advancing coronary artery disease; secondly, that patients with a mean intima-media thickness over 1.15 mm have a high likelihood (94%) of coronary artery disease ultrasound examination of the carotid arteries can effectively predict atherosclerosis of the coronary arteries; and thirdly, that there is relatively high coexistence of coronary artery disease with severe aortic arch arteries stenosis1.

A comparative study done at Johann Wolfgang Goethe University, Germany on the Prediction of Clinical Cardiovascular Events With Carotid Intima-Media Thickness concluded that the Carotid intima-media thickness is a strong predictor of future vascular events. The relative risk per intima-media thickness difference is slightly higher for the end point stroke than for myocardial infarction.For an absolute carotid IMT difference of 0.1mm, the future risk of myocardial infarction increases by 10 % to 15% 2. A prospective study done by Johann Wolfgang Goethe-University, Germany; on Carotid Intima-Media Thickening Indicates a Higher Vascular Risk Across a Wide Age range concluded that Carotid IMT independently predicts future vascular events. Its predictive value is at least as high in younger subjects as in older subjects3.

A cohort study done at Julius Center for Patient Oriented Research by Department of Neurology, University Medical Center, Netherlands on Common Carotid Intima-Media Thickness and Arterial Stiffness -Indicators of Cardiovascular Risk in High-Risk Patientsshows that Common carotid IMT and distensibility are clear markers of cardiovascular risk in patients who already have vascular disease or atherosclerotic risk factors4.

A cohort study done by Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, on The Role of Carotid Arterial Intima- Media Thickness in Predicting Clinical Coronary Events shows ultrasonographic measurement of progression of intima-media thickness in the distal common carotid artery is a useful surrogate end point for clinical coronary events5. 6.3 Objectives of the study: 1. To estimate common carotid arterial intima-media thickness and internal carotid arterial intima-media thickness. 2. To determine if carotid arterial intima-media thickness is associated with cardiovascular events.

MATERIALS AND METHODS 7.1 Source of data The study group comprises of patients with complaints of chest pain and positive ECG findings above the age group of 30 years referred to medicine department, KVG Medical College And Hospital Sullia. The control group comprises of patients in similar age group with no previous history of chest pain.

7.2 Method of collection of data Patients presenting to medicine department with complaints of chest pain and positive ECG findings above the age group of 30 years are included in the study . Controls in similar age group with no previous history of chest pain are selected. Both the groups cases and controls are evaluated by ultrasound of neck.

Further the cases and control groups underwent ultrasound examination at baseline to determine the intima-media thickness in several segments of the carotid arteries. In the Study, Common carotid artery (CCA) intima-media thickness internal carotid artery intima-media thickness will be evaluated at baseline. The incidence of myocardial infarction (MI), and death will be determined prospectively.

Inclusion criteria :

1. Cases with complaints of chest pain and positive ECG findings above the age of 30 years referred to medicine department of KVG Medical College and Hospital. Sullia. 2. Controls include patients above the age group of 30 years with no previous history of chest pain. Exclusion criteria :

 Patients less than 30yrs of age.

Study design : Comparative study (cases and controls) Study area : K V G MEDICAL COLLEGE AND HOSPITAL, SULLIA Study period : One year. From October 2012 to November 2013

Sample Size : Cases with complaints of chest pain and positive ECG findings referred to medicine department of KVG Medical College and Hospital Sullia. Sample size of 100 cases and 100 controls will be taken.

Follow up : Nil

Follow up period : Nil

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly. Yes. Ultrasonography of common carotid arteries and internal carotid arteries of both sides to measure intimomedial thickness.

7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes 8. BIBLIOGRAPHY

1. Ziembick AK; Tracz W; Przewlocki T; Pieniazek P; Sokolowski A; Konieczynska M; Association of increased carotid intima-media thickness with the extent of coronary artery disease.Heart bm journal.Heart 2004;90:1286–1290.

2. Lorenz MW; Markus HS; Bots ML ; Rosvall M ; Sitzer M; Prediction of Clinical Cardiovascular Events With Carotid Intima-Media Thickness A Systematic Review and Meta-AnalysisAmerican heart association journals .Circulation. 2007; 115:459- 467.

3. Lorenz MW; Kegler SV; Steinmetz H; Markus HS; Sitzer M; Carotid Intima-Media Thickening Indicates a Higher Vascular Risk Across a Wide Age Range.American heart association journals.Stroke. 2006;37:87-92.

4. Simons PCG; Algra A ; Bots ML ; Grobbee D ; Graaf YVD; for the SMART Study Group.Common Carotid Intima-Media Thickness and Arterial Stiffness Indicators of Cardiovascular Risk in High-Risk Patients The SMART Study (Second Manifestations of ARTerial disease).American heart association journalsCirculation. 1999;100:951-957.

5. Hodis HN; Mack WJ; LaBree L; Selzer RH ; Liu CR; Liu CH and Azen SP; The Role of Carotid Arterial Intima-Media Thickness in Predicting Clinical Coronary Events.Annals of Internal Medicine.128 (4): 262 . 9. SIGNATURE OF CANDIDATE

10. REMARKS OF THE GUIDE STUDY CAN BE CONDUCTED

11. 11.1 NAME AND DESIGNATION OF DR. SRINIVAS .S GUIDE PROFESSOR DEPARTMENT OF RADIODIAGNOSIS K.V.G. MEDICAL COLLEGE SULLIA

11.2 SIGNATURE OF THE GUIDE

11.3 HEAD OF THE DEPARTMENT DR. NITHIN KANSARA HOD AND PROFESSOR DEPARTMENT OF RADIODIAGNOSIS K.V.G. MEDICAL COLLEGE SULLIA

11.4 SIGNATURE OF THE HEAD OF THE DEPARTMENT.

12. 12.1 REMARKS OF THE PRINCIPAL:

12.2 PRINCIPAL SIGNATURE

ETHICAL COMMITTEE CLEARANCE 1. TITLE OF DISSERTATION: A COMPARATIVE STUDY OF CAROTID INTIMOMEDIAL THICKNESS AS A SURROGATE MARKER FOR CARDIOVASCULAR EVENTS IN KVG MEDICAL COLLEGE SULLIA

2. NAME OF THE CANDIDATE: Dr. SHRUNGA TEJASVI

3. NAME OF THE GUIDE: Dr. SRINIVAS S

4. APPROVED/NOT APPROVED:

ETHICAL COMMITTEE

CHAIR PERSON & LEGAL EXPERT: Mr. KRISHNAMURTHY

MEMBER SECRETARY: Dr. SUBBANNAYYA KOTIGADDE

MEMBERS:

Dr. GOPAL RAO, HOD AND PROFESSOR OF MEDICINE

Dr. MALLIKARJUN.M, PROFESSOR AND HOD OF DERMATOLOGY

Dr. VIDYASHAMBHAVA PARE,ASSO PROFESSOR OF ANATOMY

Dr. UDAYKUMAR RAO ,MEDICAL SUPERINTENDENT

Dr. CHANDRESHEKAR DAMLE, SOCIAL SCIENTIST SULLIA

Dr. SHIVA KUMAR, PROFESSOR AND HOD OF CHEMISTRY DEPARTMENT

THE PRINCIPAL K.V.G MEDICAL COLLEGE, SULLIA. DAKSHINA KANNADA INFORMED CONSENT

I, Dr. Shrunga Tejasvi, PG student, Department of Radiodiagnosis is conducting a research work for Award of MD Degree in Radiodiagnosis.

The Topic for the Study: A COMPARATIVE STUDY OF CAROTID INTIMOMEDIAL THICKNESS AS A SURROGATE MARKER FOR CARDIOVASCULAR EVENTS IN KVG MEDICAL COLLEGE SULLIA

Objectives :

1. To estimate common carotid intima-media thickness and internal carotid intima- media thickness. 2. To determine if carotid arterial intima-media thickness is associated with cardiovascular events. I hereby state that the study procedures in details were explained and all questions where fully and clearly answered to the participant / his/her relative.

S Investigator’s Signature: :

Date :

Place:

Contact Address: Dr. Shrunga Tejasvi Post Graduate Student Department of Radiodiagnosis K.V.G. Medical College Sullia Contact Number : 9986778574 I have been told in a language that I understand ( ) about the study.

I have been told that this is for a research procedure, that my participation is voluntary and I/he/she reserve the full right to withdraw from the study at my own initiative at any time, without having to give any reason and that right to participate or withdraw from the study at any stage will not prejudice my/his/her, rights and welfare. Confidentiality will be maintained and only be shared for academic purposes.

I hereby give consent to participate in the above study. I am also aware that I can withdraw this consent at any later date if I wish to. This consent form being signed voluntarily indicating my agreement to participate in the study until I decide otherwise. I understood that I will receive a signed and dated copy if this form.

I have signed this consent form before my participation in this study.

Signature of the research subject :

Date : Place:

Signature of the witness Date : Place:

PROFORMA NAME OF THE PARTICIPANT : AGE : SEX: ADDRESS: PRESENT COMPLAINTS: PAST HISTORY:

FAMILY HISTORY:

INVESTIGATIONS DONE :

SIGNATURE : WITNESS:

PLACE : DATE: