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South Asians and Coronary Plaque Registry

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ClinicalTrials.gov Identifier: NCT05367297
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Anand Rohatgi, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease Heart Diseases Diagnostic Test: Coronary CT Angiogram

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: South Asians and Coronary Plaque Registry
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : April 30, 2027
Estimated Study Completion Date : April 30, 2027
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05367297


Contacts
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Contact: Sneha Deodhar 214.648.2872 SAHealth@UTSouthwestern.edu
Contact: Anand Rohatgi 214.645.7500 SAHealth@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Sneha Deodhar    214-648-2872    Sneha.Deodhar@UTSouthwestern.edu   
Contact: Anand Rohatgi       Anand.Rohatgi@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Anand Rohatgi, MD UT Southwestern Medical Center
More Information
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Responsible Party: Anand Rohatgi, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05367297    
Other Study ID Numbers: STU2021-0948
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Coronary Disease
Myocardial Ischemia
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases