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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northwestern University
Information provided by (Responsible Party):
Alka Kanaya, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01207167
First received: September 21, 2010
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mediators of Atherosclerosis in South Asians Living in America

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Coronary artery calcium prevalence in South Asians [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid intima media thickness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Diabetes Prevalence [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 906
Study Start Date: September 2010
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207167

Locations
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
Investigators
Principal Investigator: Alka Kanaya, MD University of California, San Francisco
Principal Investigator: Namratha Kandula, MD Northwestern University
  More Information

No publications provided

Responsible Party: Alka Kanaya, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01207167     History of Changes
Other Study ID Numbers: MASALA, R01HL093009
Study First Received: September 21, 2010
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014