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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01207167
Other study ID # MASALA
Secondary ID R01HL093009R01MD
Status Recruiting
Phase
First received
Last updated
Start date September 2010
Est. completion date December 2025

Study information

Verified date March 2024
Source University of California, San Francisco
Contact Alka Kanaya, MD
Email alka.kanaya@ucsf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2314
Est. completion date December 2025
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 40 Years to 84 Years
Eligibility 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. 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

Study Design


Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States New York University New York New York
United States University of California, San Francisco San Francisco California

Sponsors (5)

Lead Sponsor Collaborator
University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI), National Institute on Minority Health and Health Disparities (NIMHD), New York University, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary artery calcium prevalence in South Asians Baseline
Secondary Carotid intima media thickness Baseline
Secondary Diabetes Prevalence Baseline
Secondary Change from baseline Coronary artery calcium prevalence in South Asians at 4 years Baseline to Year 4
Secondary Incidence of type 2 diabetes after approximately 4 years of follow-up Baseline to Year 4
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