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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06024863
Other study ID # IRBN372016/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date January 1, 2019

Study information

Verified date March 2022
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date January 1, 2019
Est. primary completion date January 1, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years and older
Eligibility Inclusion criteria: - 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. Exclusion criteria: - Patients with coronary artery disease (CAD) and - Patients with uninterpretable ST segment due to bundle branch block

Study Design


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
France Centre Hospitalier de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Silent Myocardial ischemia (SMI) Determine the frequency of exercise-induced silent myocardial ischemia (SMI). Day 1
Secondary Gender record Gender will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Age record Age will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Physical activity levels record Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Treatment record Treatment will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Cardiovascular disease (CVD) risk factors record Cardiovascular disease (CVD) risk factors will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Body mass index record Body mass index will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Score>5% record SCORE >5% will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Maximal heart record Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Maximal aerobic power record Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG Day 1
Secondary Maximal blood lactate level record Maximal blood lactate level will be collected in order to predict positive exercise ECG Day 1
Secondary Suspected SMI Exercise ECG screening test Day 1
Secondary Confirmed SMI Exercise ECG screening test Day 1
Secondary Cardiovascular events Exercise ECG screening test Day 1
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