Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05367297

Conditions

Coronary Artery Disease

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Coronary CT Angiogram

Study Details

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.

Conditions

Coronary Artery Disease

Heart Diseases

Study ID

NCT05367297

Start date

Jun 15, 2022

Status verified date

Aug, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Coronary CT Angiogram

A computerized tomography (CT) coronary angiogram is non-invasive imaging test that looks at the arteries that supply blood to your heart.

Primary outcome measure

  • Number and type of adverse and protective CTA-derived plaque features Number and type of adverse and protective CTA-derived plaque features [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Destiny Jones

214.645.2049SAHealth@UTSouthwestern.edu

Anand Rohatgi

214.645.7500SAHealth@UTSouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Destiny Jones

214-645-2049Destiny.Jones@UTSouthwestern.edu

Anand Rohatgi

Anand.Rohatgi@UTSouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-08-28.