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

Completed

• Conditions: Electrocardiography
• Interventions: Diagnostic Test: Screening stress test on a bicycle ergometer (usual practise)

• Registration Number: NCT06024863
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

The SEEPRED (Sport, Exercise ECG, prediction) prospective cohort study included leisure time sportsmen over 35 years old who performed exercise electrocardiogram (ECG) screening in the Sports Medicine Unit of the University Hospital of Saint-Etienne from September 2011 to April 2016. Personal, familial history and physical examination were systematically performed before maximal exercise electrocardiogram (ECG). Cardiovascular events and changes in physical activity were searched after exercise electrocardiogram (ECG).

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2014-01-01
• Study Completion: 2019-01-01
• Status Verified: 2022-03
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sportsmen	Screening stress test on a bicycle ergometer (usual practise)	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

Primary Outcome Measures

Name	Time	Method
Silent Myocardial ischemia (SMI)	Day 1	Determine the frequency of exercise-induced silent myocardial ischemia (SMI).

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events	Day 1	Exercise ECG screening test
Age record	Day 1	Age will be recording during medical consultation in order to predict positive exercise ECG
Physical activity levels record	Day 1	Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG
Treatment record	Day 1	Treatment will be recording during medical consultation in order to predict positive exercise ECG
Cardiovascular disease (CVD) risk factors record	Day 1	Cardiovascular disease (CVD) risk factors will be recording during medical consultation in order to predict positive exercise ECG
Maximal blood lactate level record	Day 1	Maximal blood lactate level will be collected in order to predict positive exercise ECG
Gender record	Day 1	Gender will be recording during medical consultation in order to predict positive exercise ECG
Suspected SMI	Day 1	Exercise ECG screening test
Body mass index record	Day 1	Body mass index will be recording during medical consultation in order to predict positive exercise ECG
Score>5% record	Day 1	SCORE \>5% will be recording during medical consultation in order to predict positive exercise ECG
Maximal heart record	Day 1	Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG
Maximal aerobic power record	Day 1	Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG
Confirmed SMI	Day 1	Exercise ECG screening test

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Etienne; 🇫🇷 Saint-Étienne, France