Prevalence of Myocardial Scars on CMR After COVID-19 Infection
COVID-CMR
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
1 other identifier
interventional
231
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Jun 2020
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2020
CompletedFirst Submitted
Initial submission to the registry
November 18, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2022
CompletedMarch 16, 2023
March 1, 2023
1.8 years
November 18, 2020
March 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 0
Secondary Outcomes (11)
CMR feature : Location and size of myocardial scars
Day 0
CMR feature : native T1 and T2 values
Day 0
CMR feature : extracellular volume fraction
Day 0
CMR feature : ventricular volumes
Day 0
CMR feature : ejection fraction
Day 0
- +6 more secondary outcomes
Study Arms (2)
Patient group COVID-19
EXPERIMENTAL120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization
Healthy volunteer group
ACTIVE COMPARATOR120 healthy volunteers. Age- and sex-matched controls
Interventions
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.
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.
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.
A resting 12 lead ECG will be performed at Day 0 visit.
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
You may qualify if:
- Man or woman ≥ 18 years old
- Affiliated to a health insurance program
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Grant Agreement ERC n°715093collaborator
- University of Bordeauxcollaborator
Study Sites (1)
Bordeaux University Hospital
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hubert COCHET, MD-PhD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2020
First Posted
November 19, 2020
Study Start
June 13, 2020
Primary Completion
April 4, 2022
Study Completion
April 4, 2022
Last Updated
March 16, 2023
Record last verified: 2023-03