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Mediators of Atherosclerosis in South Asians Living in America (MASALA)

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ClinicalTrials.gov Identifier: NCT01207167
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2010
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):

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 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.

Condition or disease
Atherosclerosis Cardiovascular Diseases Heart Diseases Coronary Artery Disease Coronary Disease

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mediators of Atherosclerosis in South Asians Living in America
Study Start Date : September 2010
Primary Completion Date : March 2013
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Coronary artery calcium prevalence in South Asians [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Carotid intima media thickness [ Time Frame: Baseline ]
  2. Diabetes Prevalence [ Time Frame: Baseline ]
  3. Change from baseline Coronary artery calcium prevalence in South Asians at 4 years [ Time Frame: Baseline to Year 4 ]
  4. Incidence of type 2 diabetes after approximately 4 years of follow-up [ Time Frame: Baseline to Year 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 79 years without cardiovascular disease living in the San Francisco Bay Area and Chicago Area.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207167

United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of California, San Francisco
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Alka Kanaya, MD University of California, San Francisco
Principal Investigator: Namratha Kandula, MD Northwestern University
More Information

Responsible Party: Alka Kanaya, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01207167     History of Changes
Other Study ID Numbers: MASALA
R01HL093009 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases