ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes

April 30, 2026 updated by: Baylor Research Institute
AI-Guided Coronary CT Angiography Screening in Former High-Intensity Athletes

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Former professional or collegiate high-intensity athletes (e.g., NFL alumni, Division I athletes, or equivalent competitive-level participants).
  • Age ≥30 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Athletes
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.
Device: Coronary CTA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At CCTA assessment
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.
At CCTA Assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Burden
Time Frame: Day of CCTA and biomarker collection
The secondary outcome is to correlate plaque burden with biomarkers (Lipid panel, HbA1c).
Day of CCTA and biomarker collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Cleerly, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 28, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 026-123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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