Systematic Transthoracic Echocardiographic Screening in A... | NCT06906484

Studies
Systematic Transthoracic Echocardiographic Screening in Amateur Football Referees

NCT06906484

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Cardiac Sreening
Soccer Referees

Interventions

echocardiography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 31, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2025

Last Update Posted Date

Apr 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
echocardiography	Device	analyse echocardiographic reports on cardiac abnomalies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	At the baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Referees under 18 or in training status History of cardiovascular disease Incomplete medical file

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

This study includes amateur football referees affiliated with the Normandy Football League (France) who actively officiated since the 2022 season.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de CAEN		Caen	Normandy	14000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004452	Echocardiography

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

Not provided