- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207167
Mediators of Atherosclerosis in South Asians Living in America (MASALA)
January 22, 2026 updated by: University of California, San Francisco
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.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Estimated)
2314
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- University of California, San Francisco
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-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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New York
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New York, New York, United States
- New York University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
South Asians (individuals from India, Pakistan, Nepal, Bangladesh, and Sri Lanka) adults between the ages of 40 and 84 years without cardiovascular disease living in the San Francisco Bay Area, Chicago Area, or New York City Area.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Coronary artery calcium prevalence in South Asians
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Carotid intima media thickness
Time Frame: Baseline
|
Baseline
|
|
Diabetes Prevalence
Time Frame: Baseline
|
Baseline
|
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Change from baseline Coronary artery calcium prevalence in South Asians at 4 years
Time Frame: Baseline to Year 4
|
Baseline to Year 4
|
|
Incidence of type 2 diabetes after approximately 4 years of follow-up
Time Frame: Baseline to Year 4
|
Baseline to Year 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
September 21, 2010
First Submitted That Met QC Criteria
September 21, 2010
First Posted (Estimated)
September 22, 2010
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 22, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MASALA
- R01HL093009 (U.S. NIH Grant/Contract)
- R01MD016071 (U.S. NIH Grant/Contract)
- R01HL149809 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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