sri jayadeva institute ethics committee/Bangalore/Dr.C.N.Manjunath
Approved
St. Jhons Medical College and Hospital, Institutional Ethical Review Board
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
Risk Factors for CAD,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
All patients included in the study should satisfy the following criteria.
• Age: Male patients who are less than 55 years and female patients who are less than 65 years of age
• Symptomatic for CAD or established CAD by one or all of the methods described in Section 5.1.
• Willing to sign an informed consent
ExclusionCriteria
Details
1.Age: Male patients who are greater than 55 years and female patients who are greater than 65 years of age
2. There is an absence of CAD or diagnosis of CAD by other methods than those
• by a definite imaging technique
• symptomatic for CAD and stress test positive
• who have had previous Coronary artery bypass surgery (CABG) or Percutaneous Transluminal coronary angioplasty (PTCA).
or a doubtful diagnosis of CAD.
3. Unwilling to participate in the study or sign the informed consent
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
risk factor profile of premature CAD in young Indian men (below 55 years) and women (below 65 years).
02 years
Secondary Outcome
Outcome
TimePoints
1.To assess and examine treatment variables and suggested lifestyle changes across regions pre and post-intervention.
2.To compare the prevalence of MI in the study group based on the old and new classification of MI.
3.To assess outcome with reference to practice pattern.
4.To evaluate adherence to guidelines
02 years
Target Sample Size
Total Sample Size="2000" Sample Size from India="2000" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a multicentre prospective observational study designed to examine the risk factor profile of Coronary Artery Disease in the study cohort of young. This study aims at a better understanding of the risk factors of CAD by examining patients who have an established CAD. Since the major cause of CAD in the younger age group is erratic lifestyle, eating habits and lack of exercise, this study will give a better understanding of the impact of health interventions within the Indian community. This monitoring plan is applicable to the Monitoring team of Lotus Clinical Research Academy Private Limited.