Effect of CoVid-19 (CoronaVirusDisease-19) and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias

NCT04726150 | Completed

• 1 other identifier: 1499
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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"

Conditions

Covid19; Athletes Heart; Myocarditis Viral; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (6)

• Percentage of athletes with LGE on CMR

  6months - 3 years post COVID diagnosis

• Arrhythmic Burden on ILR

  6months to 2 to3 years post implantation (depending on device longevity)

• Arrhythmic Burden on 5d Holter

  At inclusion

• Arrhythmic Burden on 5d Holter

  At 6 months

• Arrhythmic Burden on 5d Holter

  At 12 months

• Arrhythmic Burden on 5d Holter

  At 3 years

Secondary Outcomes (2)

• Occurrence of (pre)syncope or SCD

  throughout the duration of the study, preamble is 3 years

• Long-term evolution of cardiac function on echo/CMR: ejection fraction

  reevaluation at 3 years

Study Arms (3)

Mildly of Asymptomatic COVID

Athletes with prior COVID-19 that had a mildly or asymptomatic course

Other: ILR implantation

Moderate to Severe Symptoms, Cardiac Symptoms

Athletes with prior COVID-19 that had a moderate to severely symptomatic course, or who experience(d) cardiac symptoms

Other: ILR implantation

Hospitalized for

Athletes that were hospitalized for COVID-19

Other: ILR implantation

Interventions

ILR implantation OTHER

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

Hospitalized for; Mildly of Asymptomatic COVID; Moderate to Severe Symptoms, Cardiac Symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Athletes \>= 18 years if age who suffered from COVID, who are at least one month post diagnosis of COVID-19 and who are willing to start exercising again

You may qualify if:

• 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:
• have recovered from a proven (either by PCR (Polymerase Chain Reaction), serology or chest Computed Tomography) COVID-19 infection
• are more than 1-month post onset of symptoms or the first positive PCR and
• are willing to start (or are) exercising again

You may not qualify if:

• known prior cardiac fibrosis
• known or newly diagnosed coronary artery disease
• allergy or contraindications for gadolinium contrast.
• unwillingness or impossibility to give informed consent
• Presence of edema on the CMR

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Medtronic: collaborator

Study Sites (1)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken to determine the levels of hsTn

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: October 31, 2022
• Last Updated: December 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)