COIMBATORE MEDICAL COLLEGE HOSPITAL,COIMBATORE

PROFORMA APPLICATION FOR ETHICAL COMMITTEE APPROVAL

A)Title of the study:An observational study of correlation between

risk factors like Obesity,Diabetes,Hypertension,Dyslipidemia with
Carotid Intima Media Thickness in patients above 40 years of age
attending the Master health Checkup clinic .

B)Principal Investigators:Name and Designation

DR.Ushapadmini Vadivelswamy,M.D.,Senior Assistant

Professor,Department of General medicine

C)Coinvestigators:Name and Designation

DR.Manohari Ramachandran M.D.,,Associate Professor

DR.Kumar Natarajan M.D.,Professor

DR.RavishankarM.B.B.S ,DCH,Master health medical officer in

charge

DR.Murali M.D.,Professor,Radiology Department

DR.Kannadhasan,M.D.,Assistant Professor,Radiology

D)Names of the Collaborating departments:Radiology

SECTION B:Summary of the Project Attached separately as

Appendix -1

SECTIONC:Objectives of the study Attached separately as

Appendix -2

SECTIOND:Methodology

A)Where the proposed study will be undertaken:Coimbatore

Medical College Hospital

B)Duration of the project:6 months

C)Nature of the project:

1)Does the study involve Adult patients?Yes

2)Does the study involve Children?No

3)Does the study involve Normal Volunteers?No

4)Does the study Involve Psychiatric Patients?No

5)Does the study involve Pregnant Women?No

E)Is the study part of a multicentric trial?No

F)Has the trial been approved by the Ethical Committee of the

other center?No

G)Does the Study involve the use of Drugs?No

H)Clearance of Drug controller of India-Not Applicable

I)How do you propose to obtain drugs to be used in the study?Not

applicable

J)External funding if any for the Project-No

K)Does any agency have vested Interest in Outcome of the study?

No

L)Will data relating to subjects /controls be stored in Computer?

Yes

M)Can you ensure Confidentiality?Yes

N)Will the data analysis be done by the Researcher?Yes

O)Will Technical/Nurses Help required From the staff of the

hospital?Yes

P)Will you Recruit Other staff for the duration of the study?No
APPENDIX-1

INTRODUCTION:

The CIMT-Carotid intima media thickness is a simple and

Inexpensive tool which can be used to assess the Cumulative
effect of Atherosclerotic risk factors and it is also an independent
predictor of future Cardiovascular risk.The International
Atherosclerosis Project suggests that the atherosclerotic process
occurs at the same time in the Carotid,Cerebral and Coronary
arteries.Measurement of CIMT Of CCA by B mode Ultrasound is a
suitable noninvasive method to visualize the arterial walls and to
monitor the early stages of the atherosclerotic process

The Intima is the Inner most layer of the artery and Media is the
middle layer of the artery.The Intima Media Thickness is Measured
and averaged over several sites in each carotid artery.Imaging the
far wall of the Carotid artery yields more accurate and
reproducible IMT measurements than imaging of the near
wall.Two echogenic lines are produced representing the Lumen-
Intima interface and the Media Adventitia interface.The distance
between these 2 lines constitutes the IMT

It is common practice to call a CIMT>1.0mm as being abnormal

and >1.2mm as being high risk.There is general agreement that
the presence of obvious plaque indicates High risk at any
age.When there is only IMT without Plaque then the normal need
to be adjusted for Age,Gender and Perhaps even Ethnicity.

APPENDIX-2

OBJECTIVES:

-To Observe the Correlation between the risk factors like

Obesity,Diabetes,Hypertension,Dyslipidemiawith Carotid IMT in
patients above 40 years of age attending the Master health
checkup clinic

-To analyse and correlate the already occured comorbid illnesses

like Stroke and Coronary artery disease with CIMT

APPENDIX-3

METHODOLOGY:

STUDY DESIGN-OBSERVATIONAL STUDY

Patient selection:

Patients above 40 years of age attending the Master Health

Checkup Clinic

Inclusion Criteria:

All patients above 40 years with risk factors like

Obesity,Hypertension,Diabetes Dyslipidemia and those who
already had Stroke and coronary artery disease

Exclusion criteria:All patients less than 40 years and Patients who

had undergone endarterectomy for carotid stenosis

Technique:Data from patients attending master health checkup

clinic were collected and correlation made with CIMT

A)Will Informed Consent be taken?Yes

B)Design, Methodology and Techniques in brief-Attached

separately as Appendix-3
PLACE AND DATE 1 DR.V.USHAPADMINI M.D.,

SENIOR ASSISTANT
PROFESSOR

DEPARTMENT OF
GENERALMEDICINE

COIMBATORE MEDICAL
COLLEGE HOSPITAL

2 DR.MANOHARI
RAMACHANDRAN

ASSOCIATE PROFESSOR

DEPARTMENT OF GENERAL
MEDICINE

3 DR.MURALI M.D.

PROFESSOR AND H.O.D.

 DEPARTMENT OF RADIOLOGY

SIGNATURE OF HEAD OF DEPARTMENTS SIGNATURE OF DEAN

DR KUMAR NATARAJAN M.D., DR.EDWIN JOE M.D.B.L.,

PROFESSOR OF MEDICINE COIMBATORE MEDICAL

COLLEGE

COIMBATORE MEDICAL COLLEGE