Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19 (ASCCOVID19)
22. juni 2021 oppdatert av: University Hospital, Bordeaux
As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
984
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Angoulême, Frankrike, 16000
- Training center Soyaux Angoulême XV Rugby
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Aurillac, Frankrike, 15000
- Training Center Stade Aurillacois
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Bayonne, Frankrike, 64104
- Aviron Bayonnais Rugby Pro Training Center
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Biarritz, Frankrike, 64200
- Biarritz Olympique Pays Basque training center
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Bordeaux, Frankrike, 33076
- Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
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Bordeaux, Frankrike, 33076
- Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
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Brive-la-Gaillarde, Frankrike, 19100
- CABCL Rugby Training Center
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Bègles, Frankrike, 33130
- Union Bordeaux-Bègles training center
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Carcassonne, Frankrike, 11000
- US Carcassonne Rugby training center
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Colomiers, Frankrike, 31770
- Union Sportive Colomiers Rugby training center
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Grenoble, Frankrike, 38100
- FC Grenoble Rugby training center
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La Rochelle, Frankrike, 17000
- Stade Rochelais Rugby training center
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Le Plessis-Robinson, Frankrike, 92350
- Racing92 training center
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Montauban, Frankrike, 82000
- AS Montauban Rugby training center
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Nevers, Frankrike, 58000
- US Nevers Rugby training center
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Paris, Frankrike, 75016
- Stade Français training center
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Pau, Frankrike, 64000
- Section Paloise Rugby training center
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Perpignan, Frankrike, 66000
- USAP Training Center
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Romans-sur-Isère, Frankrike, 26100
- Training center Valence Romans Drôme Rugby
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Saix, Frankrike, 81710
- Castres Olympique training center
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Toulouse, Frankrike, 31200
- Stade Toulousain Rugby training center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- High level athlete,
- 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:
- Minor,
- 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).
Specific exclusion criteria for the MRI component (Contraindications):
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
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.
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.
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.
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.
To determine the rhythmic risk of athletes
High resolution MRIs is performed on 200 athletes :
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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Presence of rhythmic risk markers bye the questionnaire
Tidsramme: Day 0
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Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
Tidsramme: Day 0
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Presence or absence of repolarization disorders
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : inverted T waves
Tidsramme: Day 0
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Presence or absence of inverted T waves
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
Tidsramme: Day 0
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Presence or absence of ST segment abnormalities
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Day 0
|
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Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
Tidsramme: Day 0
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Presence or absence of QRS fragmentation
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
Tidsramme: Day 0
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Presence or absence of VES.
Ventricular extrasystoles especially with short coupling (<300ms), falling on the T wave, width > 160ms, complex forms (repetitive, several morphologies, instantaneous cycle >200bpm)
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
Tidsramme: Day 0
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Presence or absence of VT.
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Day 0
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Presence of rhythmic risk markers bye the stress test
Tidsramme: Day 0
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VES, especially with short coupling (<300ms), falling on the T wave, width > 160ms, complex shapes (repetitive, several morphologies, instantaneous cycle >200bpm), ventricular tachycardias (VT).
The analysis focus on the exercise period, and the recovery period.
Ventricular arrhythmias will be quantified.
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Day 0
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Presence of rhythmic risk markers bye ECG holter
Tidsramme: Day 0
|
VES, especially with short coupling (<300ms), falling on the T wave, width > 160ms, complex shapes (repetitive, multiple morphologies, instantaneous cycle >200bpm), ventricular tachycardias (VTs).
Ventricular arrhythmias are quantified.
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Day 0
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Presence of rhythmic risk markers bye ECG monitoring during games and trainings
Tidsramme: Day 0
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In case of moderate arrhythmia on stress test and/or Holter ECG, ECG monitoring during training sessions and matches is carried out with analysis of the tracings collected, in search of more sustained arrhythmia, particularly at the ventricular level.
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Day 0
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Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
Tidsramme: Day 0
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If the risk is perceived as very high, pharmacological tests (Isuprel®) and/or electrophysiological exploration may be performed during hospitalization, in search of dangerous rhythm disorders, particularly at the ventricular level.
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Day 0
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Presence of myocardial fibrosis by injected MRI
Tidsramme: Month 3
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In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The presence or absence of myocardial fibrosis is evaluated.
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Month 3
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Presence of transmural localization of myocardial fibrosis by injected MRI
Tidsramme: Month 3
|
In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The presence or absence of transmural localization is evaluated.
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Month 3
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Measurement of cardiac scar size by injected MRI
Tidsramme: Month 3
|
In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The size of scars is measured in milliliters (mL).
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Month 3
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Search for constitutional genetic biomarkers
Tidsramme: Month 5
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identification by sequencing of genetic variants that could have an impact on the occurrence of a severe form in individuals infected with SARS-CoV-2.
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Month 5
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Research of inflammation markers
Tidsramme: Month 5
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Th1/Th2/activation/inflammation/apoptosis markers are measured in sera by a Luminex test allowing the detection of 10 analytes with a commercial kit according to the manufacturer's instructions
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Month 5
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Antoine BENARD, MD, University Hospital, Bordeaux
- Hovedetterforsker: Laurent Chevalier, MD, Medical Center of the Bordeaux-Mérignac Sports Clinic
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. juni 2020
Primær fullføring (Faktiske)
2. mars 2021
Studiet fullført (Faktiske)
2. mars 2021
Datoer for studieregistrering
Først innsendt
2. juni 2021
Først innsendt som oppfylte QC-kriteriene
22. juni 2021
Først lagt ut (Faktiske)
23. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUBX 2020/16
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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