South Asians and Coronary Plaque Registry

Coronary Artery Disease Clinical Trial

Official title:

South Asians and Coronary Plaque Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367297
• Other study ID #: STU2021-0948
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: August 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Sneha Deodhar
• Phone: 214.648.2872
• Email: SAHealth[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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