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NCT Number: NCT06024863

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

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.

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Key information

Conditions

Electrocardiography

Age range

35 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening stress test on a bicycle ergometer (usual practise)

Diagnostic Test

Primary outcomes

  1. Silent Myocardial ischemia (SMI)

    Time frame: Day 1

    Determine the frequency of exercise-induced silent myocardial ischemia (SMI).

Secondary outcomes

  1. Gender record

    Time frame: Day 1

    Gender will be recording during medical consultation in order to predict positive exercise ECG

  2. Age record

    Time frame: Day 1

    Age will be recording during medical consultation in order to predict positive exercise ECG

  3. Physical activity levels record

    Time frame: Day 1

    Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG

  4. Treatment record

    Time frame: Day 1

    Treatment will be recording during medical consultation in order to predict positive exercise ECG

  5. Cardiovascular disease (CVD) risk factors record

    Time frame: Day 1

    Cardiovascular disease (CVD) risk factors will be recording during medical consultation in order to predict positive exercise ECG

  6. Body mass index record

    Time frame: Day 1

    Body mass index will be recording during medical consultation in order to predict positive exercise ECG

  7. Score>5% record

    Time frame: Day 1

    SCORE >5% will be recording during medical consultation in order to predict positive exercise ECG

  8. Maximal heart record

    Time frame: Day 1

    Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG

  9. Maximal aerobic power record

    Time frame: Day 1

    Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG

  10. Maximal blood lactate level record

    Time frame: Day 1

    Maximal blood lactate level will be collected in order to predict positive exercise ECG

  11. Suspected SMI

    Time frame: Day 1

    Exercise ECG screening test

  12. Confirmed SMI

    Time frame: Day 1

    Exercise ECG screening test

  13. Cardiovascular events

    Time frame: Day 1

    Exercise ECG screening test

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: SEEPRED

Important dates

Study start
2011
Primary completion
2014
Study completion
2019
First posted
Sep 6, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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