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NCT Number: NCT06831409

Using CTA Measures to Define Cardiac Risk In NFL Alumni

The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Boone Heart Institute

Greenwood Village, Colorado, 80111, United States

Location status: Recruiting

Location contact

Jeffrey Boone

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Retired NFL player

Exclusion criteria

  • CCTA not successfully processed for FFRct and AI-Plaque

Treatment and study plan

Coronary Computed Tomography Angiography

Diagnostic Test

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Participants with physiologically significant CAD

    Time frame: 24 hours from the time CCTA was taken

    • The proportion of participants with physiologically significant CAD (FFRct ≤ 0.80)

  2. Participants with high coronary plaque burden

    Time frame: 24 hours from the time CCTA was taken

    • The proportion of participants with high coronary plaque burden (>75th percentile for age- and sex-matched peers)

Study contacts

Contact information is provided by the study sponsor or research team.

HeartFlow

CONTACT

[email protected]

650-241-1221

Sponsors and collaborators

Lead sponsor

HeartFlow, Inc.

Industry

Registry information

Acronym: GAMEFILM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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