NCT01207167

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,314

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2010Apr 2027

Study Start

First participant enrolled

September 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
14.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

September 21, 2010

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Coronary artery calcium prevalence in South Asians

    Baseline

Secondary Outcomes (4)

  • Carotid intima media thickness

    Baseline

  • Diabetes Prevalence

    Baseline

  • Change from baseline Coronary artery calcium prevalence in South Asians at 4 years

    Baseline to Year 4

  • Incidence of type 2 diabetes after approximately 4 years of follow-up

    Baseline to Year 4

Eligibility Criteria

Age40 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

New York University

New York, New York, United States

Location

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesCoronary Artery DiseaseCoronary Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial Ischemia

Study Officials

  • Alka Kanaya, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Namratha Kandula, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Nadia Islam, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion (Estimated)

April 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations