Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19

NCT04936503 | Completed

• 1 other identifier: CHUBX 2020/16
• Study Type: interventional
• Target: 984
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

COVID-19; Myocarditis

Keywords

myocardial scars; MRI; Ventricular arrhythmia; Sudden cardiac death; High-level athletes

Outcome Measures

Primary Outcomes (11)

• Presence of rhythmic risk markers bye the questionnaire

  Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : repolarization disorders

  Presence or absence of repolarization disorders

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : inverted T waves

  Presence or absence of inverted T waves

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities

  Presence or absence of ST segment abnormalities

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation

  Presence or absence of QRS fragmentation

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)

  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)

  Day 0

• Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)

  Presence or absence of VT.

  Day 0

• Presence of rhythmic risk markers bye the stress test

  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.

  Day 0

• Presence of rhythmic risk markers bye ECG holter

  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.

  Day 0

• Presence of rhythmic risk markers bye ECG monitoring during games and trainings

  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.

  Day 0

• Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration

  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.

  Day 0

Secondary Outcomes (5)

• Presence of myocardial fibrosis by injected MRI

  Month 3

• Presence of transmural localization of myocardial fibrosis by injected MRI

  Month 3

• Measurement of cardiac scar size by injected MRI

  Month 3

• Search for constitutional genetic biomarkers

  Month 5

• Research of inflammation markers

  Month 5

Study Arms (1)

High-level athletes

EXPERIMENTAL

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.

Diagnostic Test: Resting electrocardiogram; Diagnostic Test: Stress test; Diagnostic Test: Cardiac echocardiography; Diagnostic Test: Cardiac rhythm monitoring; Other: Questionnaire; Device: Injected Cardiac MRI; Biological: Blood sampling for biobank

Interventions

Resting electrocardiogram DIAGNOSTIC_TEST

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.

High-level athletes

Stress test DIAGNOSTIC_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.

High-level athletes

Cardiac echocardiography DIAGNOSTIC_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 Cardiac echocardiography is performed.

High-level athletes

Cardiac rhythm monitoring DIAGNOSTIC_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 Cardiac rhythm monitoring is performed.

High-level athletes

Questionnaire OTHER

To determine the rhythmic risk of athletes

High-level athletes

Injected Cardiac MRI DEVICE

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)

High-level athletes

Blood sampling for biobank BIOLOGICAL

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).

High-level athletes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High level athlete,
• Of both sexes and age ≥ 18 years,
• Affiliated to or beneficiary of a social security system,
• Effective method of contraception for women with childbearing capacity.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (21)

Training center Soyaux Angoulême XV Rugby

Angoulême, 16000, France

Location

Training Center Stade Aurillacois

Aurillac, 15000, France

Location

Aviron Bayonnais Rugby Pro Training Center

Bayonne, 64104, France

Location

Union Bordeaux-Bègles training center

Bègles, 33130, France

Location

Biarritz Olympique Pays Basque training center

Biarritz, 64200, France

Location

Bordeaux University Hospital - CRB medical office - Hôpital du Tondu

Bordeaux, 33076, France

Location

Bordeaux University Hospital - Service UDH - Hôpital Pellegrin

Bordeaux, 33076, France

Location

CABCL Rugby Training Center

Brive-la-Gaillarde, 19100, France

Location

US Carcassonne Rugby training center

Carcassonne, 11000, France

Location

Union Sportive Colomiers Rugby training center

Colomiers, 31770, France

Location

FC Grenoble Rugby training center

Grenoble, 38100, France

Location

Stade Rochelais Rugby training center

La Rochelle, 17000, France

Location

Racing92 training center

Le Plessis-Robinson, 92350, France

Location

AS Montauban Rugby training center

Montauban, 82000, France

Location

US Nevers Rugby training center

Nevers, 58000, France

Location

Stade Français training center

Paris, 75016, France

Location

Section Paloise Rugby training center

Pau, 64000, France

Location

USAP Training Center

Perpignan, 66000, France

Location

Training center Valence Romans Drôme Rugby

Romans-sur-Isère, 26100, France

Location

Castres Olympique training center

Saïx, 81710, France

Location

Stade Toulousain Rugby training center

Toulouse, 31200, France

Location

Related Publications (1)

• 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.

  PMID: 35751748 DERIVED

MeSH Terms

Conditions

COVID-19; Myocarditis; Death, Sudden, Cardiac

Interventions

Exercise Test; Surveys and Questionnaires; Blood Specimen Collection; Biological Specimen Banks

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Antoine Bénard, MD

  University Hospital, Bordeaux

  STUDY CHAIR

• Laurent Chevalier, MD

  Medical Center of the Bordeaux-Mérignac Sports Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 23, 2021
• Study Start: June 18, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

FR (21)