ElectrocardiographySEEPREDNCT06024863
Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram
An observational study of Electrocardiography, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Electrocardiography
- What is being tested?
- Screening stress test on a bicycle ergometer (usual practise)
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2011to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Leisure tim sportmen over 35 years.
Who may be able to join
- 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.
Who cannot join
- Patients with coronary artery disease (CAD) and
- Patients with uninterpretable ST segment due to bundle branch block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Electrocardiography
- Being tested
- Screening stress test on a bicycle ergometer (usual practise)
- Keywords
- prediction, sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening stress test on a bicycle ergometer (usual practise)Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Screening stress test on a bicycle ergometer (usual practise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silent Myocardial ischemia (SMI)
Determine the frequency of exercise-induced silent myocardial ischemia (SMI).
Measured: Day 1
Secondary outcomes (13)
Gender record
Gender will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Age record
Age will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Physical activity levels record
Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Treatment record
Treatment will be recording during medical consultation in order to predict positive exercise ECG
Measured: 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
Measured: Day 1
Body mass index record
Body mass index will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Score>5% record
SCORE >5% will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Maximal heart record
Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Maximal aerobic power record
Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG
Measured: Day 1
Maximal blood lactate level record
Maximal blood lactate level will be collected in order to predict positive exercise ECG
Measured: Day 1
Suspected SMI
Exercise ECG screening test
Measured: Day 1
Confirmed SMI
Exercise ECG screening test
Measured: Day 1
Cardiovascular events
Exercise ECG screening test
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Jan 2011
- Primary completion1 Jan 2014
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElectrocardiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID HUPIN, MD, Principal investigator, CHU ST ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024863
- Sponsor's protocol ID
- IRBN372016/CHUSTE
- Acronym
- SEEPRED
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hupin D, Oriol M, Laukkanen JA, Abraham P, Dulac N, Laugier S, Trauchessec G, Carmaux A, Haber B, Bertoletti L, Costa AD, Roche F. Screening Sportsmen and Sportswomen Over Age 35: The Relevance of an Exercise Electrocardiogram. Data From the SEEPRED Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14686. doi: 10.1111/sms.14686.
PubMed 38961532
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram. The SEEPRED Study.
- ClinicalTrials.gov ID
- NCT06024863
- Acronym / sponsor ID
- SEEPRED / IRBN372016/CHUSTE
- Conditions
- Electrocardiography
- Keywords
- prediction, sport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sportsmen | – | Diagnostic Test: Screening stress test on a bicycle ergometer (usual practise)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 |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Leisure tim sportmen over 35 years.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with coronary artery disease (CAD) and
- Patients with uninterpretable ST segment due to bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening stress test on a bicycle ergometer (usual practise) | Diagnostic test | Sportsmen |
Primary outcome
Silent Myocardial ischemia (SMI)
Time frame: Day 1
Determine the frequency of exercise-induced silent myocardial ischemia (SMI).
13 secondary outcomes
Gender record
Time frame: Day 1
Age record
Time frame: Day 1
Physical activity levels record
Time frame: Day 1
Treatment record
Time frame: Day 1
Cardiovascular disease (CVD) risk factors record
Time frame: Day 1
Body mass index record
Time frame: Day 1
Score>5% record
Time frame: Day 1
Maximal heart record
Time frame: Day 1
Maximal aerobic power record
Time frame: Day 1
Maximal blood lactate level record
Time frame: Day 1
Suspected SMI
Time frame: Day 1
Confirmed SMI
Time frame: Day 1
Cardiovascular events
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 38961532Hupin D, Oriol M, Laukkanen JA, Abraham P, Dulac N, Laugier S, Trauchessec G, Carmaux A, Haber B, Bertoletti L, Costa AD, Roche F. Screening Sportsmen and Sportswomen Over Age 35: The Relevance of an Exercise Electrocardiogram. Data From the SEEPRED Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14686. doi: 10.1111/sms.14686.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID HUPIN, MD principal investigator
CHU ST ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrocardiography, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silent Myocardial ischemia (SMI) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.