COUREUR Study Myocardial Inflammation in Cyclist Part 1

NCT ID: NCT04940650

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recreational cyclists performing the 'étape du tour (EDT) de France 2021

Group Type OTHER

exercise testing

Intervention Type DIAGNOSTIC_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.

Echocardiography

Intervention Type DIAGNOSTIC_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.

Interventions

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exercise testing

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.

Intervention Type DIAGNOSTIC_TEST

Echocardiography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hasselt University

Hasselt, , Belgium

Site Status

Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 37480391 (View on PubMed)

Other Identifiers

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2021/020

Identifier Type: -

Identifier Source: org_study_id

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