An observational multicenter study to assess the risk factor profile of early Coronary Artery Disease (CAD) in Indians

Completed

• Conditions: Risk Factors for CAD

• Registration Number: CTRI/2012/12/003232
• Lead Sponsor: Lotus Clinical Research Academy

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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Unwilling to participate in the study or sign the informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk factor profile of premature CAD in young Indian men (below 55 years) and women (below 65 years).	02 years

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (21)

Apollo Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Bhagwan Mahaveer Jain Heart Centre; 🇮🇳 Bangalore, KARNATAKA, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Hospital; 🇮🇳 Bangalore, KARNATAKA, India

G.Kuppuswamy Naidu Memorial Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Jayadeva Institute of Cardiovascular Science and Research,; 🇮🇳 Bangalore, KARNATAKA, India

KIMS Hospital & Research Center; 🇮🇳 Thiruvananthapuram, KERALA, India

Kovai Medical Center and Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Life Care Institute of Medical Sciences & Research; 🇮🇳 Ahmadabad, GUJARAT, India

Madras Medical Mission; 🇮🇳 Chennai, TAMIL NADU, India

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Apollo Hospitals

🇮🇳Bangalore, KARNATAKA, India

Dr I Sathya Murthy

Principal investigator

04428290200

ismuthy@hotmail.com

Dr Ramamurthy Bingi

Principal investigator

09845009192

bingiramamurthy@yahoo.co.in