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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01207167
Recruitment Status : Active, not recruiting
First Posted : September 22, 2010
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alka Kanaya, University of California, San Francisco

Tracking Information
First Submitted Date September 21, 2010
First Posted Date September 22, 2010
Last Update Posted Date May 9, 2019
Study Start Date September 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2014)
Coronary artery calcium prevalence in South Asians [ Time Frame: Baseline ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01207167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 14, 2015)
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mediators of Atherosclerosis in South Asians Living in America
Official Title Mediators of Atherosclerosis in South Asians Living in America
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Artery Disease
  • Coronary Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 7, 2019)
1164
Original Estimated Enrollment
 (submitted: September 21, 2010)
900
Estimated Study Completion Date April 2023
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01207167
Other Study ID Numbers MASALA
R01HL093009 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alka Kanaya, University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators
  • Northwestern University
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Alka Kanaya, MD University of California, San Francisco
Principal Investigator: Namratha Kandula, MD Northwestern University
PRS Account University of California, San Francisco
Verification Date May 2019