Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram

NCT06024863 | Completed

• 1 other identifier: IRBN372016/CHUSTE
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The importance of exercise electrocardiogram (ECG) is still controversial in the prevention of cardiac events among sportsmen. The aim of this study was to assess the relevance of exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events when any cardiovascular disease (CVD) risk factors are present.

Conditions

Electrocardiography

Keywords

prediction; sport

Outcome Measures

Primary Outcomes (1)

• Silent Myocardial ischemia (SMI)

  Determine the frequency of exercise-induced silent myocardial ischemia (SMI).

  Day 1

Secondary Outcomes (13)

• Gender record

  Day 1

• Age record

  Day 1

• Physical activity levels record

  Day 1

• Treatment record

  Day 1

• Cardiovascular disease (CVD) risk factors record

  Day 1

Study Arms (1)

Sportsmen

Sportsmen (at least 1 hour of physical activity per week) over 35 years of age, referred by their doctor for a screening stress test on a bicycle ergometer in the sports medicine unit from September 2011 to August 2014

Diagnostic Test: Screening stress test on a bicycle ergometer (usual practise)

Interventions

Screening stress test on a bicycle ergometer (usual practise) DIAGNOSTIC_TEST

Sportsmen

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Leisure tim sportmen over 35 years.

You may qualify if:

• Patients referred as asymptomatic by their general practitioner for an exercise electrocardiogram (ECG) screening test carried out as a standard procedure for resuming physical activity
• Patients referred as a systematic pre-participation screening to be declared an athlete.

You may not qualify if:

• Patients with coronary artery disease (CAD) and
• Patients with uninterpretable ST segment due to bundle branch block

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

• Hupin D, Oriol M, Laukkanen JA, Abraham P, Dulac N, Laugier S, Trauchessec G, Carmaux A, Haber B, Bertoletti L, Costa AD, Roche F. Screening Sportsmen and Sportswomen Over Age 35: The Relevance of an Exercise Electrocardiogram. Data From the SEEPRED Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14686. doi: 10.1111/sms.14686.

  PMID: 38961532 DERIVED

Study Officials

• DAVID HUPIN, MD

  CHU ST ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: September 6, 2023
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2019
• Last Updated: September 8, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)