Clinical trial NCT01207167: Mediators of Atherosclerosis in South Asians Living in America
Official title: Mediators of Atherosclerosis in South Asians Living in America
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Coronary Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: New York University
First posted: 2010-09-22
Enrollment: 2314
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.


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 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

Primary outcomes:
measure: Coronary artery calcium prevalence in South Asians
timeFrame: Baseline
Secondary outcomes:
measure: Carotid intima media thickness
timeFrame: Baseline
measure: Diabetes Prevalence
timeFrame: Baseline
measure: Change from baseline Coronary artery calcium prevalence in South Asians at 4 years
timeFrame: Baseline to Year 4
measure: Incidence of type 2 diabetes after approximately 4 years of follow-up
timeFrame: Baseline to Year 4
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: University of California, San Francisco
name: Alka Kanaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Namratha Kandula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References: