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Prevalence of Myocardial Scars on CMR After COVID-19 Infection (COVID-CMR)

Primary Purpose

COVID-19, Virus Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced CMR
Exercise test ECG
Blood sample
Resting 12 lead ECG
24 hour Holter ECG
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring Myocardial Scar, Cardiac Magnetic Resonance, Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient group COVID-19

Healthy volunteer group

Arm Description

120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization

120 healthy volunteers. Age- and sex-matched controls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CMR feature : Location and size of myocardial scars
Measured in mL
CMR feature : native T1 and T2 values
Measured in milliseconds
CMR feature : extracellular volume fraction
Measured in percentage
CMR feature : ventricular volumes
Measured in mL/m2
CMR feature : ejection fraction
Measured in percentage
CMR feature : myocardial strain
Measured in percentage
ECG features
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.
Biological feature : positivity of COVID-19 serology
Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes. Measured in percentage.
Biological feature : troponin level
Measured in fg/ml
Biological feature : inflammatory markers level
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.
Genetic profile research
Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19

Full Information

First Posted
November 18, 2020
Last Updated
March 15, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Grant Agreement ERC n°715093, University of Bordeaux - mission UB-C19
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1. Study Identification

Unique Protocol Identification Number
NCT04636320
Brief Title
Prevalence of Myocardial Scars on CMR After COVID-19 Infection
Acronym
COVID-CMR
Official Title
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2020 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Grant Agreement ERC n°715093, University of Bordeaux - mission UB-C19

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Virus Disease
Keywords
Myocardial Scar, Cardiac Magnetic Resonance, Arrhythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre case-control study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient group COVID-19
Arm Type
Experimental
Arm Description
120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization
Arm Title
Healthy volunteer group
Arm Type
Active Comparator
Arm Description
120 healthy volunteers. Age- and sex-matched controls
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced CMR
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise test ECG
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Resting 12 lead ECG
Intervention Description
A resting 12 lead ECG will be performed at Day 0 visit.
Intervention Type
Diagnostic Test
Intervention Name(s)
24 hour Holter ECG
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of myocardial scars
Description
Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
CMR feature : Location and size of myocardial scars
Description
Measured in mL
Time Frame
Day 0
Title
CMR feature : native T1 and T2 values
Description
Measured in milliseconds
Time Frame
Day 0
Title
CMR feature : extracellular volume fraction
Description
Measured in percentage
Time Frame
Day 0
Title
CMR feature : ventricular volumes
Description
Measured in mL/m2
Time Frame
Day 0
Title
CMR feature : ejection fraction
Description
Measured in percentage
Time Frame
Day 0
Title
CMR feature : myocardial strain
Description
Measured in percentage
Time Frame
Day 0
Title
ECG features
Description
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.
Time Frame
Baseline and month 3
Title
Biological feature : positivity of COVID-19 serology
Description
Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes. Measured in percentage.
Time Frame
Baseline and month 3
Title
Biological feature : troponin level
Description
Measured in fg/ml
Time Frame
Day 0
Title
Biological feature : inflammatory markers level
Description
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.
Time Frame
Day 0
Title
Genetic profile research
Description
Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert COCHET, MD-PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Prevalence of Myocardial Scars on CMR After COVID-19 Infection

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