Coronary Artery DiseaseNCT05367297
South Asians and Coronary Plaque Registry
An observational study of Coronary Artery Disease and Heart Diseases, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Heart Diseases
- What is being tested?
- Coronary CT Angiogram
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Destiny Jones, 214-645-2049, Destiny.Jones@UTSouthwestern.edu
Anand Rohatgi, Anand.Rohatgi@UTSouthwestern.edu
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Heart Diseases
- Being tested
- Coronary CT Angiogram
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT AngiogramDiagnostic test
A computerized tomography (CT) coronary angiogram is non-invasive imaging test that looks at the arteries that supply blood to your heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 Jun 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Rohatgi, University of Texas Southwestern Medical Center
- Investigators
- Anand Rohatgi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367297
- Sponsor's protocol ID
- STU2021-0948
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Asians and Coronary Plaque Registry
- ClinicalTrials.gov ID
- NCT05367297
- Acronym / sponsor ID
- STU2021-0948
- Conditions
- Coronary Artery Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT AngiogramA computerized tomography (CT) coronary angiogram is non-invasive imaging test that looks at the arteries that supply blood to your heart. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Rohatgi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Heart Diseases, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Destiny Jones (214.645.2049, SAHealth@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.