search
Back to results

Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19 (ASCCOVID19)

Primary Purpose

COVID-19, Myocarditis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Resting electrocardiogram
Stress test
Cardiac echocardiography
Cardiac rhythm monitoring
Questionnaire
Injected Cardiac MRI
Blood sampling for biobank
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring myocardial scars, MRI, Ventricular arrhythmia, Sudden cardiac death, High-level athletes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Training center Soyaux Angoulême XV Rugby
  • Training Center Stade Aurillacois
  • Aviron Bayonnais Rugby Pro Training Center
  • Biarritz Olympique Pays Basque training center
  • Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
  • Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
  • CABCL Rugby Training Center
  • Union Bordeaux-Bègles training center
  • US Carcassonne Rugby training center
  • Union Sportive Colomiers Rugby training center
  • FC Grenoble Rugby training center
  • Stade Rochelais Rugby training center
  • Racing92 training center
  • AS Montauban Rugby training center
  • US Nevers Rugby training center
  • Stade Français training center
  • Section Paloise Rugby training center
  • USAP Training Center
  • Training center Valence Romans Drôme Rugby
  • Castres Olympique training center
  • Stade Toulousain Rugby training center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-level athletes

Arm Description

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.

Outcomes

Primary Outcome Measures

Presence of rhythmic risk markers bye the questionnaire
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
Presence or absence of repolarization disorders
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
Presence or absence of inverted T waves
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
Presence or absence of ST segment abnormalities
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
Presence or absence of QRS fragmentation
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)
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
Presence or absence of VT.
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.
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.
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.
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.

Secondary Outcome Measures

Presence of myocardial fibrosis by injected MRI
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.
Presence of transmural localization of myocardial fibrosis by injected MRI
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.
Measurement of cardiac scar size by injected MRI
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).
Search for constitutional genetic biomarkers
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.
Research of inflammation markers
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

Full Information

First Posted
June 2, 2021
Last Updated
June 22, 2021
Sponsor
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT04936503
Brief Title
Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
Acronym
ASCCOVID19
Official Title
Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Myocarditis
Keywords
myocardial scars, MRI, Ventricular arrhythmia, Sudden cardiac death, High-level athletes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
984 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-level athletes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Resting electrocardiogram
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Stress test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac echocardiography
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac rhythm monitoring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
To determine the rhythmic risk of athletes
Intervention Type
Device
Intervention Name(s)
Injected Cardiac MRI
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Blood sampling for biobank
Intervention Description
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).
Primary Outcome Measure Information:
Title
Presence of rhythmic risk markers bye the questionnaire
Description
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
Description
Presence or absence of repolarization disorders
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
Description
Presence or absence of inverted T waves
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
Description
Presence or absence of ST segment abnormalities
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
Description
Presence or absence of QRS fragmentation
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
Description
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)
Time Frame
Day 0
Title
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
Description
Presence or absence of VT.
Time Frame
Day 0
Title
Presence of rhythmic risk markers bye the stress test
Description
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.
Time Frame
Day 0
Title
Presence of rhythmic risk markers bye ECG holter
Description
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.
Time Frame
Day 0
Title
Presence of rhythmic risk markers bye ECG monitoring during games and trainings
Description
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.
Time Frame
Day 0
Title
Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Presence of myocardial fibrosis by injected MRI
Description
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.
Time Frame
Month 3
Title
Presence of transmural localization of myocardial fibrosis by injected MRI
Description
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.
Time Frame
Month 3
Title
Measurement of cardiac scar size by injected MRI
Description
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).
Time Frame
Month 3
Title
Search for constitutional genetic biomarkers
Description
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.
Time Frame
Month 5
Title
Research of inflammation markers
Description
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
Time Frame
Month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Bénard, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurent Chevalier, MD
Organizational Affiliation
Medical Center of the Bordeaux-Mérignac Sports Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Training center Soyaux Angoulême XV Rugby
City
Angoulême
ZIP/Postal Code
16000
Country
France
Facility Name
Training Center Stade Aurillacois
City
Aurillac
ZIP/Postal Code
15000
Country
France
Facility Name
Aviron Bayonnais Rugby Pro Training Center
City
Bayonne
ZIP/Postal Code
64104
Country
France
Facility Name
Biarritz Olympique Pays Basque training center
City
Biarritz
ZIP/Postal Code
64200
Country
France
Facility Name
Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CABCL Rugby Training Center
City
Brive-la-Gaillarde
ZIP/Postal Code
19100
Country
France
Facility Name
Union Bordeaux-Bègles training center
City
Bègles
ZIP/Postal Code
33130
Country
France
Facility Name
US Carcassonne Rugby training center
City
Carcassonne
ZIP/Postal Code
11000
Country
France
Facility Name
Union Sportive Colomiers Rugby training center
City
Colomiers
ZIP/Postal Code
31770
Country
France
Facility Name
FC Grenoble Rugby training center
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
Stade Rochelais Rugby training center
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Racing92 training center
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Facility Name
AS Montauban Rugby training center
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
US Nevers Rugby training center
City
Nevers
ZIP/Postal Code
58000
Country
France
Facility Name
Stade Français training center
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
Section Paloise Rugby training center
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
USAP Training Center
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Training center Valence Romans Drôme Rugby
City
Romans-sur-Isère
ZIP/Postal Code
26100
Country
France
Facility Name
Castres Olympique training center
City
Saix
ZIP/Postal Code
81710
Country
France
Facility Name
Stade Toulousain Rugby training center
City
Toulouse
ZIP/Postal Code
31200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35751748
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs