Mediators of Atherosclerosis in South Asians Living in America

Recruiting

• Conditions: Coronary Artery Disease; Coronary Disease; Cardiovascular Diseases; Atherosclerosis; Heart Diseases

• Registration Number: NCT01207167
• Lead Sponsor: University of California, San Francisco

Brief Summary

South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2013-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2314

Inclusion Criteria

• South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka
• age between 40 and 84 years.

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Exclusion Criteria

• Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin)
• Current atrial fibrillation
• Past history of cardiovascular procedures (coronary artery bypass graft (CABG) Surgery, angioplasty, valve replacement, pacemaker or defibrillator implantation, or any surgery on the heart or arteries)
• Active treatment for cancer
• Life expectancy less than 5 years due to serious medical illness
• Impaired cognitive ability as judged by the reviewer
• Plans to move out of the study region in next 5 years
• Weight greater than 300 pounds
• Living in a nursing home or on a waiting list
• Unable to speak/read/write English, Hindi, Urdu, or Bangla

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary artery calcium prevalence in South Asians	Baseline

Secondary Outcome Measures

Name	Time	Method
Change from baseline Coronary artery calcium prevalence in South Asians at 4 years	Baseline to Year 4
Incidence of type 2 diabetes after approximately 4 years of follow-up	Baseline to Year 4
Carotid intima media thickness	Baseline
Diabetes Prevalence	Baseline

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

New York University; 🇺🇸 New York, New York, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States