Coronary Atherosclerosis Due to Calcified Coronary LesionNCT07460583
ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes
A study testing Coronary CTA in people with Coronary Atherosclerosis Due to Calcified Coronary Lesion, run by Baylor Research Institute at 1 site in United States.
Trial summary
AI-Guided Coronary CT Angiography Screening in Former High-Intensity Athletes Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Atherosclerosis Due to Calcified Coronary Lesion
- What is being tested?
- Coronary CTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2027to 31 Jan 2027
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Former professional or collegiate high-intensity athletes (e.g., NFL alumni, Division I athletes, or equivalent competitive-level participants).
- Age ≥30 years
Who cannot join
- eGFR <40 mL/min/1.73 m²
- Known iodinated contrast allergy
- Weight >450 lbs. (scanner table limit)
- Inability to hold breath >10 seconds
- Uncontrolled arrhythmia
- Contraindication to beta-blocker, Calcium Channel Blockers and nitroglycerin
- Taking part in another research study that has not given their permission to participate in this one
- 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
Baylor Scott & White The Heart Hospital- Plano
Plano, Texas, 75093
Bonnie Ostergren, 469-814-4181, bonnie.ostergren@bswhealth.org
About this study
AI-Guided Coronary CT Angiography Screening in Former High-Intensity Athletes
Read the detailed description
A prospective, interventional, single-center study to determine the prevalence and characteristics (burden, composition, risk features) of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
- Being tested
- Coronary CTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CTADevice
The Coronary CTA will be performed for each participant. These images will be analyzed using AI-software to assess plaque quantification and an ischemia analysis, if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Experimental | This arm will have answer a questionnaire, have a physical exam performed as well as a Coronary CTA and labs completed. The Coronary CTA images will be analyzed using AI-software to assess plaque quantification and an ischemia analysis. Receives: Device: Coronary CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Coronary Atherosclerosis
The primary outcome is to determine the prevalence of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
Measured: At CCTA assessment
Coronary Atherosclerosis Characteristics
Determine the characteristics (burden, composition, risk features) of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
Measured: At CCTA Assessment
Secondary outcomes (1)
Plaque Burden
The secondary outcome is to correlate plaque burden with biomarkers (Lipid panel, HbA1c).
Measured: Day of CCTA and biomarker collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start28 Jan 2027 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Atherosclerosis Due to Calcified Coronary LesionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cleerly, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460583
- Sponsor's protocol ID
- 026-123
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes
- ClinicalTrials.gov ID
- NCT07460583
- Acronym / sponsor ID
- 026-123
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Cleerly, Inc.
- Study start
- 28 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
AI-Guided Coronary CT Angiography Screening in Former High-Intensity Athletes
Detailed description
A prospective, interventional, single-center study to determine the prevalence and characteristics (burden, composition, risk features) of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes | Experimental | Device: Coronary CTAThis arm will have answer a questionnaire, have a physical exam performed as well as a Coronary CTA and labs completed. The Coronary CTA images will be analyzed using AI-software to assess plaque quantification and an ischemia analysis. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Former professional or collegiate high-intensity athletes (e.g., NFL alumni, Division I athletes, or equivalent competitive-level participants).
- Age ≥30 years
Key exclusion criteria (8 listed)
- eGFR <40 mL/min/1.73 m²
- Known iodinated contrast allergy
- Weight >450 lbs. (scanner table limit)
- Inability to hold breath >10 seconds
- Uncontrolled arrhythmia
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 CTAThe Coronary CTA will be performed for each participant. These images will be analyzed using AI-software to assess plaque quantification and an ischemia analysis, if necessary. | Device | Athletes |
Primary outcome
Prevalence of Coronary Atherosclerosis
Time frame: At CCTA assessment
The primary outcome is to determine the prevalence of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
Coronary Atherosclerosis Characteristics
Time frame: At CCTA Assessment
Determine the characteristics (burden, composition, risk features) of coronary atherosclerosis in former high-intensity athletes using AI-guided software to analyze a CCTA.
1 secondary outcome
Plaque Burden
Time frame: Day of CCTA and biomarker collection
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 15 Oct 2026.
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Coronary Atherosclerosis Due to Calcified Coronary Lesion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary CTA in people with Coronary Atherosclerosis Due to Calcified Coronary Lesion, run by Baylor Research Institute 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 2 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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 Bonnie Ostergren (469-814-4181, bonnie.ostergren@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Coronary Atherosclerosis (time frame: At CCTA assessment). The study lists 2 primary outcomes in all. 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 15 Oct 2026.