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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT06024863

Collaborator

(none)

1,500

Enrollment

Location

Actual Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Electrocardiography	Diagnostic Test: Screening stress test on a bicycle ergometer (usual practise)

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 Design

Study Type:

Observational

Actual Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram. The SEEPRED Study.

Actual Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Silent Myocardial ischemia (SMI) [Day 1]
Determine the frequency of exercise-induced silent myocardial ischemia (SMI).

Secondary Outcome Measures

Gender record [Day 1]
Gender will be recording during medical consultation in order to predict positive exercise ECG
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
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
Maximal blood lactate level record [Day 1]
Maximal blood lactate level will be collected in order to predict positive exercise ECG
Suspected SMI [Day 1]
Exercise ECG screening test
Confirmed SMI [Day 1]
Exercise ECG screening test
Cardiovascular events [Day 1]
Exercise ECG screening test

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de Saint-Etienne	Saint-Étienne		France	42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: DAVID HUPIN, MD, CHU ST ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT06024863

Other Study ID Numbers:

IRBN372016/CHUSTE

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

prediction

sport

Study Results

No Results Posted as of Sep 8, 2023