NCT06831409

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 17, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

February 12, 2025

Last Update Submit

August 25, 2025

Conditions

Coronary Artery Disease (CAD)Heart DiseaseCoronary Atherosclerosis

Keywords

NFLHeart Disease

Outcome Measures

Primary Outcomes (1)

  • Participants with CAD

    The proportion of participants with coronary artery disease demonstrated on coronary computed tomography angiography (CCTA).

    24 hours from the time CCTA was taken

Secondary Outcomes (2)

  • Participants with physiologically significant CAD

    24 hours from the time CCTA was taken

  • Participants with high coronary plaque burden

    24 hours from the time CCTA was taken

Study Arms (1)

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

Interventions

Coronary computed tomography angiographyDIAGNOSTIC_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.

NFL Alumni

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Retired NFL player

You may not qualify if:

  • CCTA not successfully processed for FFRct and AI-Plaque

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boone Heart Institute

Greenwood Village, Colorado, 80111, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jeffrey Boone

    Boone Heart Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HeartFlow

CONTACT

650-241-1221GAMEFILM@heartflow.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 18, 2025

Study Start

December 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

US(1)