Coronary Artery Disease (CAD)GAMEFILMNCT06831409
Using CTA Measures to Define Cardiac Risk In NFL Alumni
An observational study of Coronary Artery Disease (CAD) and Heart Disease, run by HeartFlow, Inc. at 1 site in United States.
Trial summary
The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Heart Disease, Coronary Atherosclerosis
- What is being tested?
- Coronary computed tomography angiography
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Retired NFL player
Who cannot join
- CCTA not successfully processed for FFRct and AI-Plaque
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boone Heart Institute
Greenwood Village, Colorado, 80111
Jeffrey Boone
About this study
The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.
Read the 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.
- Being tested
- Coronary computed tomography angiography
- Keywords
- NFL, Heart Disease
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| NFL Alumni | A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster. Receives: Diagnostic Test: Coronary computed tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with CAD
The proportion of participants with coronary artery disease demonstrated on coronary computed tomography angiography (CCTA).
Measured: 24 hours from the time CCTA was taken
Secondary outcomes (2)
Participants with physiologically significant CAD
- The proportion of participants with physiologically significant CAD (FFRct ≤ 0.80)
Measured: 24 hours from the time CCTA was taken
Participants with high coronary plaque burden
- The proportion of participants with high coronary plaque burden (>75th percentile for age- and sex-matched peers)
Measured: 24 hours from the time CCTA was taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start17 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Boone, Principal investigator, Boone Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831409
- Sponsor's protocol ID
- 11072024
- Acronym
- GAMEFILM
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CTA Measures to Define Cardiac Risk In NFL Alumni
- ClinicalTrials.gov ID
- NCT06831409
- Acronym / sponsor ID
- GAMEFILM / 11072024
- Keywords
- NFL, Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NFL Alumni | – | Diagnostic Test: Coronary computed tomography angiographyA retired NFL player is defined as any former player who made either a practice squad or an active NFL roster. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Retired NFL player
Key exclusion criteria (1 listed)
- CCTA not successfully processed for FFRct and AI-Plaque
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary computed tomography angiographyCoronary 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. | Diagnostic test | NFL Alumni |
Primary outcome
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).
2 secondary outcomes
Participants with physiologically significant CAD
Time frame: 24 hours from the time CCTA was taken
Participants with high coronary plaque burden
Time frame: 24 hours from the time CCTA was taken
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Boone principal investigator
Boone Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Heart Disease, run by HeartFlow, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HeartFlow (650-241-1221, GAMEFILM@heartflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with CAD (time frame: 24 hours from the time CCTA was taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.