COVID-19ASCCOVID19NCT04936503
Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
A study testing Resting electrocardiogram, Stress test and Cardiac echocardiography in people with COVID-19 and Myocarditis, run by University Hospital, Bordeaux at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Myocarditis
- What is being tested?
- Resting electrocardiogram, Stress test and Cardiac echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 21 sitesFrance
- Study dates
- 18 Jun 2020to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Training center Soyaux Angoulême XV Rugby
Angoulême, 16000
Training Center Stade Aurillacois
Aurillac, 15000
Aviron Bayonnais Rugby Pro Training Center
Bayonne, 64104
Union Bordeaux-Bègles training center
Bègles, 33130
Biarritz Olympique Pays Basque training center
Biarritz, 64200
Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
Bordeaux, 33076
Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
Bordeaux, 33076
CABCL Rugby Training Center
Brive-la-Gaillarde, 19100
US Carcassonne Rugby training center
Carcassonne, 11000
Union Sportive Colomiers Rugby training center
Colomiers, 31770
FC Grenoble Rugby training center
Grenoble, 38100
Stade Rochelais Rugby training center
La Rochelle, 17000
Racing92 training center
Le Plessis-Robinson, 92350
AS Montauban Rugby training center
Montauban, 82000
US Nevers Rugby training center
Nevers, 58000
Stade Français training center
Paris, 75016
Section Paloise Rugby training center
Pau, 64000
USAP Training Center
Perpignan, 66000
Training center Valence Romans Drôme Rugby
Romans-sur-Isère, 26100
Castres Olympique training center
Saïx, 81710
Stade Toulousain Rugby training center
Toulouse, 31200
About this study
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.
Read more
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
- Being tested
- Resting electrocardiogram, Stress test, Cardiac echocardiography, Cardiac rhythm monitoring, Questionnaire
- Keywords
- myocardial scars, MRI, Ventricular arrhythmia, Sudden cardiac death, High-level athletes
- Medical subject headings
- COVID-19, Myocarditis, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting electrocardiogramDiagnostic 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.
Stress testDiagnostic 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 echocardiographyDiagnostic 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.
Cardiac rhythm monitoringDiagnostic 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.
QuestionnaireOther
To determine the rhythmic risk of athletes
Injected Cardiac MRIDevice
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 biobankBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of rhythmic risk markers bye the questionnaire
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Measured: Day 0
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
Presence or absence of repolarization disorders
Measured: Day 0
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
Presence or absence of inverted T waves
Measured: Day 0
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
Presence or absence of ST segment abnormalities
Measured: Day 0
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
Presence or absence of QRS fragmentation
Measured: 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)
Measured: Day 0
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
Presence or absence of VT.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Secondary outcomes (5)
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.
Measured: Month 3
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.
Measured: Month 3
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).
Measured: Month 3
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.
Measured: Month 5
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
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start18 Jun 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Bénard, MD, Study chair, University Hospital, BordeauxLaurent Chevalier, MD, Principal investigator, Medical Center of the Bordeaux-Mérignac Sports Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936503
- Sponsor's protocol ID
- CHUBX 2020/16
- Acronym
- ASCCOVID19
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35751748
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
- ClinicalTrials.gov ID
- NCT04936503
- Acronym / sponsor ID
- ASCCOVID19 / CHUBX 2020/16
- Conditions
- COVID-19, Myocarditis
- Keywords
- myocardial scars, MRI, Ventricular arrhythmia, Sudden cardiac death, High-level athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-level athletes | Experimental | 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 biobankHigh 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting electrocardiogramAn 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. | Diagnostic test | High-level athletes |
| Stress testIn 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. | Diagnostic test | High-level athletes |
| Cardiac echocardiographyIn 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. | Diagnostic test | High-level athletes |
| Cardiac rhythm monitoringIn 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. | Diagnostic test | High-level athletes |
| QuestionnaireTo determine the rhythmic risk of athletes | Other | High-level athletes |
| Injected Cardiac MRIHigh 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) | Device | High-level athletes |
| Blood sampling for biobankFor 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). | Biological | High-level athletes |
Primary outcome
Presence of rhythmic risk markers bye the questionnaire
Time frame: Day 0
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
Time frame: Day 0
Presence or absence of repolarization disorders
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
Time frame: Day 0
Presence or absence of inverted T waves
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
Time frame: Day 0
Presence or absence of ST segment abnormalities
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
Time frame: Day 0
Presence or absence of QRS fragmentation
Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
Time frame: Day 0
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)
Time frame: Day 0
Presence or absence of VT.
Presence of rhythmic risk markers bye the stress test
Time frame: Day 0
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
Time frame: 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.
Presence of rhythmic risk markers bye ECG monitoring during games and trainings
Time frame: Day 0
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
Time frame: Day 0
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.
5 secondary outcomes
Presence of myocardial fibrosis by injected MRI
Time frame: Month 3
Presence of transmural localization of myocardial fibrosis by injected MRI
Time frame: Month 3
Measurement of cardiac scar size by injected MRI
Time frame: Month 3
Search for constitutional genetic biomarkers
Time frame: Month 5
Research of inflammation markers
Time frame: Month 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 35751748Chevalier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Bénard, MD study chair
University Hospital, Bordeaux
Laurent Chevalier, MD principal investigator
Medical Center of the Bordeaux-Mérignac Sports Clinic
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting electrocardiogram, Stress test and Cardiac echocardiography in people with COVID-19 and Myocarditis, run by University Hospital, Bordeaux at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of rhythmic risk markers bye the questionnaire (time frame: Day 0). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.