Mediators of Atherosclerosis in South Asians Living in Am... | NCT01207167

Studies
Mediators of Atherosclerosis in South Asians Living in America

NCT01207167

Sponsor

University of California, San Francisco

Status

Active, not recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

2,314Estimated

Phase

Not provided

Conditions

Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Coronary Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Link
R01HL093009	U.S. NIH Grant/Contract	View source
R01MD016071	U.S. NIH Grant/Contract	View source
R01HL149809	U.S. NIH Grant/Contract	View source

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2027Estimated

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Name	Class
Northwestern University	OTHER
National Heart, Lung, and Blood Institute (NHLBI)	NIH
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,314Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary artery calcium prevalence in South Asians		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Carotid intima media thickness		Baseline
Diabetes Prevalence		Baseline
Change from baseline Coronary artery calcium prevalence in South Asians at 4 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94115	United States
Northwestern University

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D003324	Coronary Artery Disease
D003327	Coronary Disease

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided