Cardiac Assessment After Covid-19 Disease in Elite Altheltic Population (CADE)

Evaluation of Cardiological Tests Before Returning to Sport in Athletes After COVID-19 Infection (CADE Study)

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.

Study Overview

• Status: Unknown
• Conditions: Covid19

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High-level athlete (professionals or high-level ministerial list) who had a recent COVID 19 infection, symptomatic or not

Description

Inclusion criteria:

• High-level athlete
• recent COVID 19 infection, symptomatic or not
• evidence of COVID 19 infection by PCR or serology

Exclusion criteria:

- subject opposition

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
High-level athlete who had a recent COVID 19 infection, symptomatic or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of cardiac abnormality	Prevalence of cardiac abnormality encountered during examinations performed in athletes before resuming intense sport, after infection with COVID-19	1 to 3 weeks after COVID-19 infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic variables	Demographic variables associated with detected cardiac abnormalities	1 to 3 weeks after COVID-19 infection

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Centre Hospitalier Universitaire de Nīmes; Rennes University Hospital; Clinique du Millenaire; CHU de Perpignan; ligue nationale de Basket
• Investigators: Principal Investigator: Stéphane CADE, MD, Clinique du Millenaire, Montpellier, France; Study Director: Christophe HEDON, MD, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: High-level athlete; recent COVID 19 infection, symptomatic or not
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RECHMPL20_0648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No