Official Title
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Brief Summary

The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.

Detailed Description

Multiple large series conducted in hospitalized patients have reported high rates of
myocardial injuries in the acute stage of COVID-19 infection. These findings have raised
concerns regarding potential long term consequences of the pandemic on cardiovascular
diseases (heart failure and sudden cardiac deaths due to scar-related arrhythmias). However,
the prevalence of silent myocardial injuries in the general population who presented a
COVID-19 infection managed without hospitalization are unknown. In addition, the propensity
of these scars to generate arrhythmias have not been thoroughly studied. COVID CMR will
include 120 patients with history of laboratory-proven symptomatic COVID-19 infection managed
without hospitalization and 120 age- and sex-matched controls. At day 1, all subjects will
undergo a 12-lead electrocardiogram, a contrast-enhanced CMR study including advanced methods
to detect silent myocardial scars, and a blood sample to look for markers of inflammation and
cardiac injury, and to assess the COVID-19 serological status at the time of the CMR study.
The prevalence of myocardial scars on CMR will be compared between the 2 groups. In a second
visit at 3 months, patients showing myocardial scar on CMR will be matched to healthy
volunteers showing no such scars, and these 2 population subsets will undergo exercise
electrocardiogram (ECG) and 24 hour Holter ECG to characterize the arrhythmogenic role of
silent myocardial scars.

Completed
COVID-19
Virus Disease

Device: Contrast-enhanced CMR

Cardiac Magnetic Resonance Imaging (MRI) examinations will be performed at Day 0 visit on clinical systems 1.5 equipped with specific antennas for cardiac imaging. The imaging protocol will last approximately 50 minutes.

Diagnostic Test: Exercise test ECG

A treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit.
Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.

Biological: Blood sample

A blood sample will be taken at Day 0 visit for COVID-19 serology, hematocrit measurement, ultra-high sensitive troponin test, low grade markers of inflammation, genetic profiling.
An other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers.

Diagnostic Test: Resting 12 lead ECG

A resting 12 lead ECG will be performed at Day 0 visit.

Diagnostic Test: 24 hour Holter ECG

A 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.

Eligibility Criteria

Inclusion Criteria:

- Man or woman ≥ 18 years old

- Affiliated to a health insurance program

- Providing free, informed, written and signed consent to participate (at the latest on
the day of inclusion and before any research procedure is initiated)

- Effective contraception if women in the age to procreate

- In the patient group : history of COVID-19 infection with either a positive Reverse
Transcriptase Polymerase Chain Reaction (RT-PCR) test on nasopharyngeal swab or a
positive COVID-19 serology in the acute stage. Presence of all following symptoms in
the acute stage: fever>38°C, asthenia, arthromyalgia, associated with at least 2 of
the following: coughing and/or spitting, dyspnea and/or chest discomfort, anosmia
and/or ageusia.

Exclusion Criteria:

- age < 18 years old

- History of cardiac disease or acute coronary syndrome associated with troponin rise

- History of allergic reaction to gadolinium-based contrast agents

- History of severe renal failure

- Presence of a pacemaker, implantable defibrillator, intra-orbital metallic material,
intra-cranial surgical clip, valve prosthesis Star-Edwards pre 6000, neurostimulator
or implantable insulin pump

- Claustrophobia or inability to lay on the back for 50 min

- Pregnant or breast feeding women

- Inability to express informed consent

- Person deprived of liberty by judicial or administrative decision

- Person under legal protection

- In the healthy volunteer group:

- Symptoms suggestive of COVID-19 infection over the epidemic period (after
February 1st 2020)

- Person not willing to be informed of potential incidental CMR findings

- In the patient group:

- Hospitalization for infectious syndrome suggestive of COVID-19.

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

Bordeaux University Hospital
Pessac, France

Hubert COCHET, MD-PhD, Principal Investigator
University Hospital, Bordeaux

University Hospital, Bordeaux
NCT Number
Keywords
Myocardial Scar
Cardiac Magnetic Resonance
Arrhythmia
MeSH Terms
COVID-19
Virus Diseases