Using CTA Measures to Define Cardiac Risk In NFL Alumni (GAMEFILM)

August 25, 2025 updated by: HeartFlow, Inc.
The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the prevalence and severity of CAD in NFL alumni. A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster. Approximately 300 participants will be included from approximately 20 sites in the US.

Study Type

Observational

Enrollment (Estimated)

300

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

  • United States
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Recruiting
        • Boone Heart Institute
        • Contact:
          • Jeffrey Boone

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population is retired NFL alumni. A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster.

Description

Inclusion Criteria:

  • Retired NFL player

Exclusion Criteria:

  • CCTA not successfully processed for FFRct and AI-Plaque

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NFL Alumni
A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster.
Diagnostic test: Coronary computed tomography angiography
Coronary Computed Tomography Angiography (CCTA) is a non-invasive medical imaging test that uses X-rays to create detailed 3D images of the heart and its blood vessels, specifically the coronary arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with CAD
Time Frame: 24 hours from the time CCTA was taken
The proportion of participants with coronary artery disease demonstrated on coronary computed tomography angiography (CCTA).
24 hours from the time CCTA was taken

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with physiologically significant CAD
Time Frame: 24 hours from the time CCTA was taken
1. The proportion of participants with physiologically significant CAD (FFRct ≤ 0.80)
24 hours from the time CCTA was taken
Participants with high coronary plaque burden
Time Frame: 24 hours from the time CCTA was taken
2. The proportion of participants with high coronary plaque burden (>75th percentile for age- and sex-matched peers)
24 hours from the time CCTA was taken

Collaborators and Investigators

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

Sponsor

HeartFlow, Inc.

Investigators

  • Principal Investigator: Jeffrey Boone, Boone Heart Institute

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 (Actual)

December 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11072024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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