Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04726150 |
| Other study ID # |
1499 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
University Hospital, Antwerp |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
COVID-19 can cause myocarditis, which can cause myocardial fibrosis. This has been shown to
increase mortality and morbidity among athletes. Several efforts have been made to guide
sports participation after COVID-19, but not much scientific evidence is present to back-up
those guidelines. The current initiative aims gain a heightened insight in this matter.To
identify the presence of fibrosis athletes who recovered from COVID-19 will undergo CMR
(Cardiac MRI). All athletes will also undergo echocardiography, 5-day Holtermonitoring among
others. This will allow to determine whether differences between those with and those without
fibrosis are present. If fibrosis is present, athletes will be offered an implantation of a
very small monitoring device that will be able to detect arrhythmias with a much higher
sensitivity. Also an exercise echocardiography will be performed, to determine the safety of
continuation of athletic efforts.
Amendment:
Recently myocarditis and pericarditis have also been observed after the administration of
mRNA-vaccines, specifically after the second dose. The effect of vaccination on exercise
capacity is less clear. To investigate this we propose to amend the inclusion criteria for
COVIDEX with "athletes undergoing or having undergone COVID vaccination"
Description:
Baseline investigations will depend on the clinical presentation of the athlete. Three groups
are identified:
1. Asymptomatic/mildly symptomatic: anosmia, ageusia, headache, mild fatigue, fever ≤3d,
myalgias ≤3d , mild upper respiratory tract illness, and mild gastrointestinal illness
2. Moderate to severe symptoms: at least 2 of: persistent fever ≥4d, chills ≥4d, myalgias
≥4d, lethargy impairing activities of daily life (ADL) ≥4d, dyspnea during ADL ≥4d, and
chest tightness ≥4d. Or cardiac symptoms: dyspnea, exercise intolerance, chest
tightness, dizziness, (pre)syncope, and (new onset) palpitations.
3. Hospitalized: all athletes admitted for COVID-19, whether or not on the intensive care
unit.
- Group 1 will undergo a thorough history, clinical examination, ECG, laboratory
tests for hs-Troponin T (TnT) and hsCRP, echocardiography at rest, 5-day-Holter and
CMR. These examinations will take place at least 30 days after the first symptoms
or positive test. Follow-up will be performed as pointed out with the grey crosses
in the table. Depending on the results further investigation may be required (as in
group 2 and 3). This part of the study is interventional in nature (not according
to standard of care in those individuals).
- Groups 2 and 3 will undergo a more extensive evaluation: a thorough history,
clinical examination, ECG, laboratory tests for hs-TnT and hsCRP, echocardiography
at rest, CardioPulmonary Exercise Test (CPET), 5-day-Holter, late potentials and
CMR.
If in any athlete the CMR shows signs of fibrosis or myocarditis, an exercise
echocardiography will be performed additionally. Those subjects will be part of a more
extensive follow-up schedule (both white and grey in the table) In the case of the presence
of a non-ischemic pattern of Late Gadolinium Enhancement (LGE) or raised myocardial T2 and
normal of only mildly contractile reserve, implantation of an Implantable Loop Recorder (ILR)
will be performed as a part of the study. This then will be remotely followed-up through
telemonitoring. Other athletes (and those who refuse an ILR will receive a 5d-Holter
monitoring.
Amendment:
Athletes having undergone complete vaccination will be asked to provide the investigators
with their training data prior to and following boostervaccination. Those athletes undergo
investigations already included in the COVIDEX study, albeit in a condensed manner
(Ergospirometry, Echocardiography and Blood Sample). These tests will take place at the day
before the second vaccination and seven days after. Those athletes will also be asked to
provide the investigators with their training data prior to and following vaccination.
