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

Electrocardiography Clinical Trial

— SEEPRED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06024863
• Other study ID #: IRBN372016/CHUSTE
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Electrocardiography

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