South Asians and Coronary Plaque Registry

• ClinicalTrials.gov Identifier: NCT05367297
• Recruitment Status: Recruiting
• First Posted: May 10, 2022
• Last Update Posted: August 22, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Anand Rohatgi, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: April 12, 2022
• First Posted Date: May 10, 2022
• Last Update Posted Date: August 22, 2023
• Actual Study Start Date: June 15, 2022
• Estimated Primary Completion Date: April 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 4, 2022)

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 ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: South Asians and Coronary Plaque Registry
• Official Title: South Asians and Coronary Plaque Registry
• 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.

Detailed Description

To establish a registry of individuals who self-report as South Asian ethnicity with coronary plaque assessment to better understand plaque characteristics in this high-risk group and facilitate future studies investigating the increased coronary disease risk in this population.

South Asian individuals (SAs) are an expanding minority group in the United States (U.S.) with marked excess cardio-metabolic risk. SAs (primarily India, Pakistan, Bangladesh, Nepal, Sri Lanka) are one of the fastest-growing minority groups in the U.S., with an estimated 40% population growth from 2010-2017 (5.4 million in 2017).1-3 SAs in diaspora countries have markedly increased risk of atherosclerotic cardiovascular disease (ASCVD), particularly coronary heart disease (CHD), compared with most other races, ethnicities, and nationalities.4-5 In analysis of census-derived CVD mortality from 2003-2010 across 34 states in the U.S. with over 10 million death records,6 SAs, unlike other Asian groups, had a higher proportionate mortality ratio for ASCVD compared to non-Hispanic White Americans. Similarly, recent data from California revealed an adjusted 2-fold increased incidence of CHD in SA vs. White individuals.7 Moreover, SAs often present with premature ASCVD (7-10 years younger than White persons)8, 9 and more diffuse ASCVD (multiple vascular territories), a consistent finding across diaspora countries.10 The global cardiovascular community has officially recognized SA ethnicity as a "risk-enhancing factor" in the 2018 ACC/AHA Prevention Guidelines11 as well as by incorporating various SA countries of origin in the QRISK2/3 risk calculator used in the U.K.12 Reducing morbidity and mortality from ASCVD in SAs is a clear priority and unmet need.

Prior studies of coronary calcium have not distinguished differences in calcification of coronary artery plaques in this high-risk group, perhaps because arterial plaque calcification is a late-stage process related to aging. Given the premature presentation of coronary disease in SAs and the well-established observation in predominantly White individuals that non-calcified plaque features lead to plaque rupture and myocardial infarction. Therefore, characterizing non-calcified plaque features in SAs may lead to a better understanding of the increased risk in this population and more tailored preventive strategies.

Coronary CT angiogram (CCTA) provide detail information about plaque characteristics and fully assesses both calcified and non-calcified plaque features in the coronary arteries. This information cannot be obtained by any other imaging test and certainly no blood test. CCTA is considered a Class I indication for assessment of chest pain based on its prognostic potential and is a routine test with low risk. The Swedish Cardiopulmonary Bioimage Study used CCTA in 25000 participants without known coronary artery disease to study prevalence, severity and characteristics of coronary atherosclerosis.13 Miami Heart Study, a US based cohort of healthy individuals, performed prospective CCTA measurements in over 2500 participants to understand pathophysiology of subclinical atherosclerosis and investigate its role in genesis of clinical cardiovascular disease.14

Linking novel blood-based markers with these refined plaque features by CCTA may provide a better understanding of what is driving the increased coronary heart disease in South Asians and could lead to earlier prevention and treatment. Since South Asians have a 2-fold higher risk of heart disease and comprise ~60% of all heart disease globally, this is a major clinical problem that deserves increased investigation.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: 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).

Condition

• Coronary Artery Disease
• Heart Diseases

Intervention

Diagnostic Test: 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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 4, 2022): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2027
• Estimated Primary Completion Date: April 30, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Sneha Deodhar; 214.648.2872; SAHealth@UTSouthwestern.edu

Contact: Anand Rohatgi; 214.645.7500; SAHealth@UTSouthwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05367297
• Other Study ID Numbers: STU2021-0948
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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.

• Current Responsible Party: Anand Rohatgi, University of Texas Southwestern Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anand Rohatgi, MD; UT Southwestern Medical Center

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: August 2023