Official Title
Effect of CoVid-19 and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias (CovidEx)
Brief 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"

Detailed 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.

Active, not recruiting
COVID19
Athletes Heart
Myocarditis Viral
Ventricular Arrythmia

Other: ILR implantation

If LGE is present on CMR, ILR implantation will be proposed

Eligibility Criteria

Inclusion Criteria:

- Athletes (professional or recreational but aiming to compete at a national or
international level), performing mixed-type or endurance sports as defined by
Pelliccia et al. who:

1. have recovered from a proven (either by PCR (Polymerase Chain Reaction), serology
or chest Computed Tomography) COVID-19 infection

2. are more than 1-month post onset of symptoms or the first positive PCR and

3. are willing to start (or are) exercising again

Exclusion Criteria:

1. known prior cardiac fibrosis

2. known or newly diagnosed coronary artery disease

3. allergy or contraindications for gadolinium contrast.

4. unwillingness or impossibility to give informed consent

5. Presence of edema on the CMR

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
Locations

University Hospital Antwerp
Antwerp, Belgium

NCT Number
MeSH Terms
COVID-19
Arrhythmias, Cardiac
Myocarditis