Using CTA Measures to Define Cardiac Risk In NFL Alumni

Recruiting

• Conditions: Coronary Artery Disease (CAD); Heart Disease; Coronary Atherosclerosis

• Registration Number: NCT06831409
• Lead Sponsor: HeartFlow, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2024-12-17
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Retired NFL player

Exclusion Criteria

• CCTA not successfully processed for FFRct and AI-Plaque

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants with CAD	24 hours from the time CCTA was taken	The proportion of participants with coronary artery disease demonstrated on coronary computed tomography angiography (CCTA).

Secondary Outcome Measures

Name	Time	Method
Participants with physiologically significant CAD	24 hours from the time CCTA was taken	1. The proportion of participants with physiologically significant CAD (FFRct ≤ 0.80)
Participants with high coronary plaque burden	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)

Trial Locations

Locations (2)

Stanford; 🇺🇸 Stanford, California, United States

Boone Heart Institute; 🇺🇸 Greenwood Village, Colorado, United States