Mediators of Atherosclerosis in South Asians Living in America

Coronary Artery Disease Clinical Trial

— MASALA  

Official title:

Mediators of Atherosclerosis in South Asians Living in America

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01207167
• Other study ID #: MASALA
• Secondary ID: R01HL093009R01MD
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases

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