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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01207167
Other study ID # MASALA
Secondary ID R01HL093009
Status Enrolling by invitation
Phase N/A
First received September 21, 2010
Last updated May 1, 2017
Start date September 2010
Est. completion date April 2019

Study information

Verified date May 2017
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date April 2019
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 40 Years to 79 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States University of California, San Francisco San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary artery calcium prevalence in South Asians Baseline
Secondary Carotid intima media thickness Baseline
Secondary Diabetes Prevalence Baseline
Secondary Change from baseline Coronary artery calcium prevalence in South Asians at 4 years Baseline to Year 4
Secondary Incidence of type 2 diabetes after approximately 4 years of follow-up Baseline to Year 4
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