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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alka Kanaya, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01207167
First received: September 21, 2010
Last updated: May 1, 2017
Last verified: May 2017

September 21, 2010
May 1, 2017
September 2010
March 2013   (Final data collection date for primary outcome measure)
Coronary artery calcium prevalence in South Asians [ Time Frame: Baseline ]
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Complete list of historical versions of study NCT01207167 on ClinicalTrials.gov Archive Site
  • Carotid intima media thickness [ Time Frame: Baseline ]
  • Diabetes Prevalence [ Time Frame: Baseline ]
  • Change from baseline Coronary artery calcium prevalence in South Asians at 4 years [ Time Frame: Baseline to Year 4 ]
  • Incidence of type 2 diabetes after approximately 4 years of follow-up [ Time Frame: Baseline to Year 4 ]
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Mediators of Atherosclerosis in South Asians Living in America
Mediators of Atherosclerosis in South Asians Living in America
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
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.
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Artery Disease
  • Coronary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
April 2019
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01207167
MASALA
R01HL093009 ( US NIH Grant/Contract Award Number )
No
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Alka Kanaya, University of California, San Francisco
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
University of California, San Francisco
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP