MASALA: Mediators of Atherosclerosis in South Asians Living in America

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT01207167

Collaborator

Northwestern University (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Institute on Minority Health and Health Disparities (NIMHD) (NIH), New York University (Other)

2,314

Enrollment

Locations

183

Duration (Months)

771.3

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Cardiovascular Diseases Heart Diseases Coronary Artery Disease Coronary Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

2314 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mediators of Atherosclerosis in South Asians Living in America

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Coronary artery calcium prevalence in South Asians [Baseline]

Secondary Outcome Measures

Carotid intima media thickness [Baseline]
Diabetes Prevalence [Baseline]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115
2	Northwestern University	Chicago	Illinois	United States	60611
3	New York University	New York	New York	United States

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alka Kanaya, MD, University of California, San Francisco
Principal Investigator: Namratha Kandula, MD, Northwestern University
Principal Investigator: Nadia Islam, PhD, New York University