Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
NCT ID: NCT04936503
Last Updated: 2021-06-23
Study Results
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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COMPLETED
NA
984 participants
INTERVENTIONAL
2020-06-18
2021-03-02
Brief Summary
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Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.
The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.
Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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High-level athletes
High level athletes are rugby players, intervention unit agents of the National Police, sports students.
Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality.
The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects.
Resting electrocardiogram
An ECG at rest is performed for all participants at Day 0. A centralized reading is performed by one of the 6 expert cardiologists participating in the research.
Stress test
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a stress test is performed.
Cardiac echocardiography
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac echocardiography is performed.
Cardiac rhythm monitoring
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac rhythm monitoring is performed.
Questionnaire
To determine the rhythmic risk of athletes
Injected Cardiac MRI
High resolution MRIs is performed on 200 athletes :
* 100 athletes without rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
* 100 athletes with rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
Blood sampling for biobank
For all athletes included at the D0 inclusion visit, a centralized COVID-19 serology is performed to search for biomarkers associated with the occurrence of myocardial fibrosis: analysis of genetic determinants in relation to cardiac damage.
For athletes who have performed MRI: Search for biomarkers associated with the occurrence of myocardial fibrosis: analyses of low-grade inflammation markers (cytokine assay and fibrosis markers).
Interventions
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Resting electrocardiogram
An ECG at rest is performed for all participants at Day 0. A centralized reading is performed by one of the 6 expert cardiologists participating in the research.
Stress test
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a stress test is performed.
Cardiac echocardiography
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac echocardiography is performed.
Cardiac rhythm monitoring
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac rhythm monitoring is performed.
Questionnaire
To determine the rhythmic risk of athletes
Injected Cardiac MRI
High resolution MRIs is performed on 200 athletes :
* 100 athletes without rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
* 100 athletes with rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
Blood sampling for biobank
For all athletes included at the D0 inclusion visit, a centralized COVID-19 serology is performed to search for biomarkers associated with the occurrence of myocardial fibrosis: analysis of genetic determinants in relation to cardiac damage.
For athletes who have performed MRI: Search for biomarkers associated with the occurrence of myocardial fibrosis: analyses of low-grade inflammation markers (cytokine assay and fibrosis markers).
Eligibility Criteria
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Inclusion Criteria
* Of both sexes and age ≥ 18 years,
* Affiliated to or beneficiary of a social security system,
* Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research),
* Effective method of contraception for women with childbearing capacity.
Exclusion Criteria
* History of ventricular arrhythmia, myocarditis, identified coronary artery disease or documented myocardial fibrosis,
* Pregnant or breastfeeding women,
* Person unable to give informed consent,
* Person deprived of liberty by judicial or administrative decision,
* Adults subject to a legal protection measure (guardianship, curator, safeguard of justice).
* Subject with an implantable pacemaker or defibrillator, intraocular metallic foreign body, intracranial metallic clip, pre 6000 Starr-Edwards type cardiac valve prosthesis, or biomedical device such as insulin pump or neurostimulator,
* Hypersensitivity to gadolinium or to one of the excipients of the contrast product used,
* Claustrophobic subjects or those unable to remain in an immobile lying position for 30 minutes,
* Renal insufficiency with creatinine clearance of less than 30 ml/min,
* A patient whose shoulder width does not allow installation in the MRI machine.
18 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Antoine Bénard, MD
Role: STUDY_CHAIR
University Hospital, Bordeaux
Laurent Chevalier, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Center of the Bordeaux-Mérignac Sports Clinic
Locations
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Training center Soyaux Angoulême XV Rugby
Angoulême, , France
Training Center Stade Aurillacois
Aurillac, , France
Aviron Bayonnais Rugby Pro Training Center
Bayonne, , France
Union Bordeaux-Bègles training center
Bègles, , France
Biarritz Olympique Pays Basque training center
Biarritz, , France
Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
Bordeaux, , France
Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
Bordeaux, , France
CABCL Rugby Training Center
Brive-la-Gaillarde, , France
US Carcassonne Rugby training center
Carcassonne, , France
Union Sportive Colomiers Rugby training center
Colomiers, , France
FC Grenoble Rugby training center
Grenoble, , France
Stade Rochelais Rugby training center
La Rochelle, , France
Racing92 training center
Le Plessis-Robinson, , France
AS Montauban Rugby training center
Montauban, , France
US Nevers Rugby training center
Nevers, , France
Stade Français training center
Paris, , France
Section Paloise Rugby training center
Pau, , France
USAP Training Center
Perpignan, , France
Training center Valence Romans Drôme Rugby
Romans-sur-Isère, , France
Castres Olympique training center
Saïx, , France
Stade Toulousain Rugby training center
Toulouse, , France
Countries
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References
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Chevalier L, Cochet H, Mahida S, S SB, Benard A, Cariou T, Sridi-Cheniti S, Benhenda S, Doutreleau S, Cade S, Guerard S, Guy JM, Trimoulet P, Picard S, Dusfour B, Pouzet A, Roseng S, Franchi M, Jais P, Pellegrin I; ASCCOVID Investigators. Resuming Training in High-Level Athletes After Mild COVID-19 Infection: A Multicenter Prospective Study (ASCCOVID-19). Sports Med Open. 2022 Jun 25;8(1):83. doi: 10.1186/s40798-022-00469-0.
Other Identifiers
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CHUBX 2020/16
Identifier Type: -
Identifier Source: org_study_id
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