Myocardial InflammationNCT04940650
COUREUR Study Myocardial Inflammation in Cyclist Part 1
A study testing exercise testing and Echocardiography in people with Myocardial Inflammation, run by Jessa Hospital at 2 sites in Belgium.
Trial summary
The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myocardial Inflammation
- What is being tested?
- exercise testing and Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Jun 2021to 1 Oct 2023
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride
Who cannot join
- presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases and the intake of anti-inflammatory drugs.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1
The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.
Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study.
In part 1 of the study, each participant will complete a detailed questionnaire detailing their training history and an echocardiography at rest will be performed. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.
- Conditions
- Myocardial Inflammation
- Being tested
- exercise testing, Echocardiography
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise testingDiagnostic test
To define the strenuous physical exercise in this study, each participant will be asked to perform two hours of high intensity (HIT)-effort during the endurance exercise of at least 6 to 7 hours. Therefore all participants will have exercise testing approximately 1 week before the physical exercise to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.
EchocardiographyDiagnostic test
Measurements of mass, volumes and function will be obtained of both the left and right ventricles at rest enabling comparisons with cardiac MRI and traditional echo measures.
| Study group | Role | What they receive |
|---|---|---|
| Recreational cyclists performing the 'étape du tour (EDT) de France 2021 | Other | Not described Receives: Diagnostic Test: exercise testing; Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Aerobic and anaerobic gas exchange heart rate thresholds, and VO2max (ml/kg/min) will be measured in all cyclists approximately 1 week before the high intense exercise. This exercise testing will be performed to evaluate high-intensity exercise as factor of exercise-induced myocardial inflammation in cyclists.
Measured: approximately 1 week before the strenuous exercise
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Assessments of weight (in kilograms) and heigth (in meters) to determine VO2 max (ml/kg/min)
Measured: approximately 1 week before the strenuous exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start16 Jun 2021
- Primary completion5 Jul 2021
- Study completion1 Oct 2023
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 Myocardial InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940650
- Sponsor's protocol ID
- 2021/020
- Status last verified
- Oct 2023
- First submitted
- 18 Jun 2021
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghekiere O, Herbots L, Peters B, Berg BV, Dresselaers T, Franssen W, Padovani B, Ducreux D, Ferrari E, Nchimi A, Demanez S, De Bosscher R, Willems R, Heidbuchel H, La Gerche A, Claessen G, Bogaert J, Eijnde BO. Exercise-induced myocardial T1 increase and right ventricular dysfunction in recreational cyclists: a CMR study. Eur J Appl Physiol. 2023 Oct;123(10):2107-2117. doi: 10.1007/s00421-023-05259-4. Epub 2023 Jul 22.
PubMed 37480391
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1
- ClinicalTrials.gov ID
- NCT04940650
- Acronym / sponsor ID
- 2021/020
- Conditions
- Myocardial Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Jun 2021 (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 study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.
Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study.
In part 1 of the study, each participant will complete a detailed questionnaire detailing their training history and an echocardiography at rest will be performed. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recreational cyclists performing the 'étape du tour (EDT) de France 2021 | Other | Diagnostic Test: exercise testing, Diagnostic Test: Echocardiography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride
Key exclusion criteria (1 listed)
- presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases and the intake of anti-inflammatory drugs.
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 |
|---|---|---|
| exercise testingTo define the strenuous physical exercise in this study, each participant will be asked to perform two hours of high intensity (HIT)-effort during the endurance exercise of at least 6 to 7 hours. Therefore all participants will have exercise testing approximately 1 week before the physical exercise to set aerobic and anaerobic gas exchange thresholds, as well as VO2max. | Diagnostic test | Recreational cyclists performing the 'étape du tour (EDT) de France 2021 |
| EchocardiographyMeasurements of mass, volumes and function will be obtained of both the left and right ventricles at rest enabling comparisons with cardiac MRI and traditional echo measures. | Diagnostic test | Recreational cyclists performing the 'étape du tour (EDT) de France 2021 |
Primary outcome
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Time frame: approximately 1 week before the strenuous exercise
Aerobic and anaerobic gas exchange heart rate thresholds, and VO2max (ml/kg/min) will be measured in all cyclists approximately 1 week before the high intense exercise. This exercise testing will be performed to evaluate high-intensity exercise as factor of exercise-induced myocardial inflammation in cyclists.
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Time frame: approximately 1 week before the strenuous exercise
Assessments of weight (in kilograms) and heigth (in meters) to determine VO2 max (ml/kg/min)
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 12 Oct 2023.
- Derived from this study: PubMed 37480391Ghekiere O, Herbots L, Peters B, Berg BV, Dresselaers T, Franssen W, Padovani B, Ducreux D, Ferrari E, Nchimi A, Demanez S, De Bosscher R, Willems R, Heidbuchel H, La Gerche A, Claessen G, Bogaert J, Eijnde BO. Exercise-induced myocardial T1 increase and right ventricular dysfunction in recreational cyclists: a CMR study. Eur J Appl Physiol. 2023 Oct;123(10):2107-2117. doi: 10.1007/s00421-023-05259-4. Epub 2023 Jul 22.
Related trials for Myocardial Inflammation
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
Not yet recruitingObservational study
Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
Immune Checkpoint Inhibitor-Related Myocarditis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise testing and Echocardiography in people with Myocardial Inflammation, run by Jessa Hospital at 2 sites in Belgium.
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 1 inclusion and 1 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1 (time frame: approximately 1 week before the strenuous exercise). The study lists 2 primary outcomes in all. 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 NCT04940650, 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 12 Oct 2023.