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

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

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.

Study Overview

• Status: Completed
• Conditions: Electrocardiography
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CENTRE HOSPITALIER DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Leisure tim sportmen over 35 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Silent Myocardial ischemia (SMI)	Determine the frequency of exercise-induced silent myocardial ischemia (SMI).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender record	Gender will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Age record	Age will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Physical activity levels record	Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Treatment record	Treatment will be recording during medical consultation in order to predict positive exercise ECG	Day 1
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
Body mass index record	Body mass index will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Score>5% record	SCORE >5% will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Maximal heart record	Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Maximal aerobic power record	Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG	Day 1
Maximal blood lactate level record	Maximal blood lactate level will be collected in order to predict positive exercise ECG	Day 1
Suspected SMI	Exercise ECG screening test	Day 1
Confirmed SMI	Exercise ECG screening test	Day 1
Cardiovascular events	Exercise ECG screening test	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: DAVID HUPIN, MD, CHU ST Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: prediction; sport
• Other Study ID Numbers: IRBN372016/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No