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Completed

NCT Number: NCT04636320

Prevalence of Myocardial Scars on CMR After COVID-19 Infection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast-enhanced CMR

Device

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.

Exercise test ECG

Diagnostic Test

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.

Blood sample

Biological

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.

Resting 12 lead ECG

Diagnostic Test

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

24 hour Holter ECG

Diagnostic Test

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

Primary outcomes

  1. Prevalence of myocardial scars

    Time frame: Day 0

    Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.

Secondary outcomes

  1. CMR feature : Location and size of myocardial scars

    Time frame: Day 0

    Measured in mL

  2. CMR feature : native T1 and T2 values

    Time frame: Day 0

    Measured in milliseconds

  3. CMR feature : extracellular volume fraction

    Time frame: Day 0

    Measured in percentage

  4. CMR feature : ventricular volumes

    Time frame: Day 0

    Measured in mL/m2

  5. CMR feature : ejection fraction

    Time frame: Day 0

    Measured in percentage

  6. CMR feature : myocardial strain

    Time frame: Day 0

    Measured in percentage

  7. ECG features

    Time frame: Baseline and month 3

    Repolarization abnormalities, T wave inversion, ST segment abnormalities, QRS fractionation, atrial arrhythmias, premature ventricular beats or ventricular tachycardia.These will be assessed at the time of CMR study on a resting 12-lead ECG recording and on exercise 12-lead ECG and 24-hour Holter ECG recordings.

  8. Biological feature : positivity of COVID-19 serology

    Time frame: Baseline and month 3

    Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes.

    Measured in percentage.

  9. Biological feature : troponin level

    Time frame: Day 0

    Measured in fg/ml

  10. Biological feature : inflammatory markers level

    Time frame: Day 0

    Markers of inflammation and fibrosis will be sought. The Th1/Th2/activation/inflammation/apoptosis markers will be measured in the sera by a Luminex test allowing the detection of 48 analytes.

  11. Genetic profile research

    Time frame: Day 0

    Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Grant Agreement ERC n°715093
  • University of Bordeaux

Registry information

Official study title

Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection

Acronym: COVID-CMR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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