Covid19CADENCT04653857
Cardiac Assessment After Covid-19 Disease in Elite Altheltic Population
An observational study of Covid19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
COVID-19 infection coud induce cardiac injuries. Before returning to sport, cardiac evaluation is recommended by sports federations, based on the precautionary principle and the opinion of expert consensus. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Covid19
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Jan 2021
- Phase
- Observational
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: High-level athlete (professionals or high-level ministerial list) who had a recent COVID 19 infection, symptomatic or not
Who may be able to join
- High-level athlete
- recent COVID 19 infection, symptomatic or not
- evidence of COVID 19 infection by PCR or serology
Who cannot join
- subject opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiological Tests Before Returning to Sport in Athletes After COVID-19 Infection (CADE Study)
COVID-19 infection coud induce cardiac injuries. Before returning to sport, cardiac evaluation is recommended by sports federations, based on the precautionary principle and the opinion of expert consensus.
The aim of this study is to to determine the prevalence of abnormalities in cardiological examinations realized in athletes who have suffered from COVID-19 infection, symptomatic or not.
Read the detailed description
Cardiac injuries linked to COVID-19 infection are frequently described in symptomatic and hospitalized people and are associated with a poorer prognosis. The question of possible myocardial damage in people without or moderately symptomatic is less established. The presence of a myocarditis associated with COVID-19 infection is a key issue for the sports cardiologist since this cardiac inflammation may be associated with an increased risk of sudden death in the athlete.
In absence of scientific data and on the basis of the precautionary principle, the ministry (Guide to health recommendations for sports resumption, Sports French Ministry, May 2020), sports federations and certain expert consensus have proposed in May 2020 after being released from lockdown, algorithms for carrying out systematic cardiac examinations before resuming intense sport (professional or high-level athletes). These algorithms typically provide a comprehensive cardiac assessment with resting ECG, resting echocardiography, and maximal exercice test. The performance of cardiac MRI, the most sensitive exam for detecting possible myocarditis, remains at the discretion of the cardiologist depending on the interpretation of the first examinations.
Given a much larger screening for COVID-19 infection than in March, with the performance of virological PCR tests required weekly by certain sports federations, the prevalence of COVID-19 infection is important in the athletic population, mostly in a- or pauci-symptomatic athletes. In case of positivity, a cardiac evaluation is therefore often recommended.
The aim of this study is to determine the prevalence of cardiac abnormality encountered during cardiac examinations performed in athletes before resuming intense sport, after infection with COVID-19.
The target population is High-level athlete (professionals or high-level ministerial list), who had a recent COVID 19 infection, symptomatic or not
To perform this study, the investigators will use existing data from patients' medical records (March 2019, March 2021). Anonymized data will be provided to the methodological team for analysis. The data will be kept for 2 years after publication. The data collected will be :
- the sport practiced
- Age and sex
- Date of positive PCR
- Classification of the symptom intensities related to COVID-19 infection: (asymptomatic, mild symptoms, moderate symptoms, cardiac symptoms)
- 12-lead resting electrocardiogram (heart rate, interpretation by the cardiologist, anomaly or not)
- Maxmal exercice test (maximum heart rate, maximum power or speed, oxygen saturation, presence of arrhythmia or not)
- Resting echocardiography (LVEF, overall LV longitudinal strain, abnormal or not in segmental kinetics, presence or not of pericardial effusion)
- MRI (if done): LVEF, presence of an abnormality or not, in particular late enhancement
- Holter ECG if done (presence or not of arrhythmia)
- Biology if done (increase or not in troponin or D-Dimers
- Conditions
- Covid19
- Keywords
- High-level athlete, recent COVID 19 infection, symptomatic or not
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-level athlete who had a recent COVID 19 infection, symptomatic or not | High-level athlete who had a recent COVID 19 infection, symptomatic or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac abnormality
Prevalence of cardiac abnormality encountered during examinations performed in athletes before resuming intense sport, after infection with COVID-19
Measured: 1 to 3 weeks after COVID-19 infection
Secondary outcomes (1)
Demographic variables
Demographic variables associated with detected cardiac abnormalities
Measured: 1 to 3 weeks after COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Apr 2020
- Primary completion30 Apr 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique du Millenaire, Centre Hospitalier Universitaire de Nīmes, Perpignan Hospital Center, ligue nationale de Basket, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Stéphane CADE, MD, Principal investigator, Clinique du Millenaire, Montpellier, FranceChristophe HEDON, MD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653857
- Sponsor's protocol ID
- RECHMPL20_0648
- Acronym
- CADE
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiological Tests Before Returning to Sport in Athletes After COVID-19 Infection (CADE Study)
- ClinicalTrials.gov ID
- NCT04653857
- Acronym / sponsor ID
- CADE / RECHMPL20_0648
- Conditions
- Covid19
- Keywords
- High-level athlete, recent COVID 19 infection, symptomatic or not
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Clinique du Millenaire, Centre Hospitalier Universitaire de Nīmes, Perpignan Hospital Center, ligue nationale de Basket, Rennes University Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 4 Dec 2020 (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.
COVID-19 infection coud induce cardiac injuries. Before returning to sport, cardiac evaluation is recommended by sports federations, based on the precautionary principle and the opinion of expert consensus.
The aim of this study is to to determine the prevalence of abnormalities in cardiological examinations realized in athletes who have suffered from COVID-19 infection, symptomatic or not.
Detailed description
Cardiac injuries linked to COVID-19 infection are frequently described in symptomatic and hospitalized people and are associated with a poorer prognosis. The question of possible myocardial damage in people without or moderately symptomatic is less established. The presence of a myocarditis associated with COVID-19 infection is a key issue for the sports cardiologist since this cardiac inflammation may be associated with an increased risk of sudden death in the athlete.
In absence of scientific data and on the basis of the precautionary principle, the ministry (Guide to health recommendations for sports resumption, Sports French Ministry, May 2020), sports federations and certain expert consensus have proposed in May 2020 after being released from lockdown, algorithms for carrying out systematic cardiac examinations before resuming intense sport (professional or high-level athletes). These algorithms typically provide a comprehensive cardiac assessment with resting ECG, resting echocardiography, and maximal exercice test. The performance of cardiac MRI, the most sensitive exam for detecting possible myocarditis, remains at the discretion of the cardiologist depending on the interpretation of the first examinations.
Given a much larger screening for COVID-19 infection than in March, with the performance of virological PCR tests required weekly by certain sports federations, the prevalence of COVID-19 infection is important in the athletic population, mostly in a- or pauci-symptomatic athletes. In case of positivity, a cardiac evaluation is therefore often recommended.
The aim of this study is to determine the prevalence of cardiac abnormality encountered during cardiac examinations performed in athletes before resuming intense sport, after infection with COVID-19.
The target population is High-level athlete (professionals or high-level ministerial list), who had a recent COVID 19 infection, symptomatic or not
To perform this study, the investigators will use existing data from patients' medical records (March 2019, March 2021). Anonymized data will be provided to the methodological team for analysis. The data will be kept for 2 years after publication. The data collected will be :
- the sport practiced
- Age and sex
- Date of positive PCR
- Classification of the symptom intensities related to COVID-19 infection: (asymptomatic, mild symptoms, moderate symptoms, cardiac symptoms)
- 12-lead resting electrocardiogram (heart rate, interpretation by the cardiologist, anomaly or not)
- Maxmal exercice test (maximum heart rate, maximum power or speed, oxygen saturation, presence of arrhythmia or not)
- Resting echocardiography (LVEF, overall LV longitudinal strain, abnormal or not in segmental kinetics, presence or not of pericardial effusion)
- MRI (if done): LVEF, presence of an abnormality or not, in particular late enhancement
- Holter ECG if done (presence or not of arrhythmia)
- Biology if done (increase or not in troponin or D-Dimers
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-level athlete who had a recent COVID 19 infection, symptomatic or not | – | –High-level athlete who had a recent COVID 19 infection, symptomatic or not |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- High-level athlete (professionals or high-level ministerial list) who had a recent COVID 19 infection, symptomatic or not
Key inclusion criteria (3 listed)
- High-level athlete
- recent COVID 19 infection, symptomatic or not
- evidence of COVID 19 infection by PCR or serology
Key exclusion criteria (1 listed)
- subject opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of cardiac abnormality
Time frame: 1 to 3 weeks after COVID-19 infection
Prevalence of cardiac abnormality encountered during examinations performed in athletes before resuming intense sport, after infection with COVID-19
1 secondary outcome
Demographic variables
Time frame: 1 to 3 weeks after COVID-19 infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Stéphane CADE, MD principal investigator
Clinique du Millenaire, Montpellier, France
Christophe HEDON, MD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Prevalence of cardiac abnormality (time frame: 1 to 3 weeks after COVID-19 infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2020.