This trial is active, not recruiting.

Conditions atherosclerosis, cardiovascular diseases, heart diseases, coronary artery disease, coronary disease
Sponsor University of California, San Francisco
Collaborator Northwestern University
Start date September 2010
End date March 2013
Trial size 906 participants
Trial identifier NCT01207167, MASALA, R01HL093009


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 two 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Coronary artery calcium prevalence in South Asians
time frame: Baseline

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 79 years old.

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 79 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 or Urdu

Additional Information

Official title Mediators of Atherosclerosis in South Asians Living in America
Principal investigator Alka Kanaya, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.