South Asians and Coronary Plaque Registry
1 other identifier
observational
300
1 country
1
Brief Summary
Individuals who self-report as SAs will be recruited to participate in this registry as well as non-SA controls for comparison. All individuals who consent to participate will 1) complete a survey assessing demographics, medical history, family medical history; 2) have blood collection; 3) and CCTA assessment. These data will be combined with clinical data from the electronic health record and, if applicable, the Dallas Hearts and Mind Study and other research studies, for research purposes. The registry will serve to generate primary observations as well as preliminary data for future studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
August 28, 2025
August 1, 2025
4.9 years
April 12, 2022
August 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number and type of adverse and protective CTA-derived plaque features Number and type of adverse and protective CTA-derived plaque features
There will be several features derived from CTA that are validated adverse features, including plaque volume, thin cap, low attenuation, and necrotic core. Protective features include fibrous cap thickness.
Day 1
Interventions
A computerized tomography (CT) coronary angiogram is non-invasive imaging test that looks at the arteries that supply blood to your heart.
Eligibility Criteria
Adults with South Asian descent (South Asians to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh) and non South Asian Adult volunteers (age 18 years or older).
You may qualify if:
- Males and Females: Age 18 years or above
- South Asian (SA) adults through self-identification (South Asians to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh)
- We also propose to enroll an equivalent number of individuals of other descent as a comparator group (Non SA Adult Volunteers)
- Sampling Method: Probability Sample
You may not qualify if:
- Under the age of 18 years
- Unable to give informed consent
- Impaired renal function: estimated glomerular filtration rate ≤ 45ml/min
- Baseline heart rate≥70 bpm or ≥66 bpm after beta blocker
- Body mass index (BMI) of 35 or greater
- Prior anaphylactic/non-anaphylactic reaction or other contraindication to iodinated contrast
- Anyone who cannot do CCTA for any reason
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Rohatgi, MD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 12, 2022
First Posted
May 10, 2022
Study Start
June 15, 2022
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data will become available after completed enrollment of any participant. The data will be available for the duration of the registry.
- Access Criteria
- Researchers may request data from the PI, Dr. Anand Rohatgi. Once approval is given and appropriate regulatory approvals are in place, access may be granted and data shared.
Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.