Clinical trial NCT04636320: Prevalence of Myocardial Scars on CMR After COVID-19 Infection
Official title: Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Virus Disease
Keywords: Myocardial Scar
Cardiac Magnetic Resonance
Arrhythmia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Grant Agreement ERC n°715093
name: University of Bordeaux
First posted: 2020-11-19
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre case-control study
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Prevalence of myocardial scars
timeFrame: Day 0
Secondary outcomes:
measure: CMR feature : Location and size of myocardial scars
timeFrame: Day 0
measure: CMR feature : native T1 and T2 values
timeFrame: Day 0
measure: CMR feature : extracellular volume fraction
timeFrame: Day 0
measure: CMR feature : ventricular volumes
timeFrame: Day 0
measure: CMR feature : ejection fraction
timeFrame: Day 0
measure: CMR feature : myocardial strain
timeFrame: Day 0
measure: ECG features
timeFrame: Baseline and month 3
measure: Biological feature : positivity of COVID-19 serology
timeFrame: Baseline and month 3
measure: Biological feature : troponin level
timeFrame: Day 0
measure: Biological feature : inflammatory markers level
timeFrame: Day 0
measure: Genetic profile research
timeFrame: Day 0
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Hubert COCHET, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: