University Hospital Antwerp
Antwerp, 2650, Belgium
NCT Number: NCT04726150
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"
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Notify Me18 year and older
All sexes
Observational
Antwerp, 2650, Belgium
Baseline investigations will depend on the clinical presentation of the athlete. Three groups are identified:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If LGE is present on CMR, ILR implantation will be proposed
Time frame: 6months - 3 years post COVID diagnosis
Time frame: 6months to 2 to3 years post implantation (depending on device longevity)
Time frame: At inclusion
Time frame: At 6 months
Time frame: At 12 months
Time frame: At 3 years
Time frame: throughout the duration of the study, preamble is 3 years
Time frame: reevaluation at 3 years
University Hospital, Antwerp
Other
Effect of CoVid-19 and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias (CovidEx)
Acronym: CoViDEx
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