Cardiac SreeningNCT06906484
Systematic Transthoracic Echocardiographic Screening in Amateur Football Referees
An observational study of Cardiac Sreening and Soccer Referees, run by University Hospital, Caen at 1 site in France.
Trial summary
This retrospective study aims to evaluate the prevalence of cardiac abnormalities detected by transthoracic echocardiography (TTE) in amateur football referees as part of a systematic cardiovascular screening program. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Sreening, Soccer Referees
- What is being tested?
- echocardiography
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes amateur football referees affiliated with the Normandy Football League (France) who actively officiated since the 2022 season.
Who may be able to join
- Male amateur football referees, aged ≥18 Affiliated with the Normandy Football League Completed a baseline TTE No known pre-existing cardiac disease Complete medical records available
Who cannot join
- Referees under 18 or in training status History of cardiovascular disease Incomplete medical file
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Systematic Echocardiography in the Cardiovascular Screening of Amateur Football Referees
This retrospective study aims to evaluate the prevalence of cardiac abnormalities detected by transthoracic echocardiography (TTE) in amateur football referees as part of a systematic cardiovascular screening program.
Read the detailed description
cardiovasculaire screening of athletes and sports officials is essential for preventing sudden cardiac death during physical activity. In 2019, the French Football Federation (FFF) introduced mandatory transthoracic echocardiography (TTE) for amateur referees over 18 years old, to improve early detection of cardiovascular abnormalities.
This retrospective observational study investigates the diagnostic value of systematic TTE in detecting structural or functional cardiac anomalies among adult amateur referees affiliated with the Normandy Football League.
The primary objective is to estimate the prevalence of cardiac abnormalities diagnosed by TTE in this population. The secondary objectives include identifying the prevalence of cardiovascular risk factors (CVRFs), and describing the abnormalities found during the medical evaluation
- Conditions
- Cardiac Sreening, Soccer Referees
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
analyse echocardiographic reports on cardiac abnomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of structural or functional abnormalities detected by TTE
The primary outcome is the proportion of participants presenting with significant structural or functional cardiac abnormalities detected by resting transthoracic echocardiography performed as part of the mandatory cardiovascular screening for amateur football referees.
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SreeningStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906484
- Sponsor's protocol ID
- REF-TTE
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Systematic Echocardiography in the Cardiovascular Screening of Amateur Football Referees
- ClinicalTrials.gov ID
- NCT06906484
- Acronym / sponsor ID
- REF-TTE
- Conditions
- Cardiac Sreening, Soccer Referees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 2 Apr 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.
This retrospective study aims to evaluate the prevalence of cardiac abnormalities detected by transthoracic echocardiography (TTE) in amateur football referees as part of a systematic cardiovascular screening program.
Detailed description
cardiovasculaire screening of athletes and sports officials is essential for preventing sudden cardiac death during physical activity. In 2019, the French Football Federation (FFF) introduced mandatory transthoracic echocardiography (TTE) for amateur referees over 18 years old, to improve early detection of cardiovascular abnormalities.
This retrospective observational study investigates the diagnostic value of systematic TTE in detecting structural or functional cardiac anomalies among adult amateur referees affiliated with the Normandy Football League.
The primary objective is to estimate the prevalence of cardiac abnormalities diagnosed by TTE in this population. The secondary objectives include identifying the prevalence of cardiovascular risk factors (CVRFs), and describing the abnormalities found during the medical evaluation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes amateur football referees affiliated with the Normandy Football League (France) who actively officiated since the 2022 season.
Key inclusion criteria (1 listed)
- Male amateur football referees, aged ≥18 Affiliated with the Normandy Football League Completed a baseline TTE No known pre-existing cardiac disease Complete medical records available
Key exclusion criteria (1 listed)
- Referees under 18 or in training status History of cardiovascular disease Incomplete medical file
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 |
|---|---|---|
| echocardiographyanalyse echocardiographic reports on cardiac abnomalies | Device | – |
Primary outcome
Prevalence of structural or functional abnormalities detected by TTE
Time frame: At the baseline
The primary outcome is the proportion of participants presenting with significant structural or functional cardiac abnormalities detected by resting transthoracic echocardiography performed as part of the mandatory cardiovascular screening for amateur football referees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Sreening and Soccer Referees, run by University Hospital, Caen at 1 site in France.
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: finished, as of the sponsor's last update on 2 Apr 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of structural or functional abnormalities detected by TTE (time frame: At the baseline). 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 2 Apr 2025.