Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04653857 |
| Other study ID # |
RECHMPL20_0648 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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
