Prevalence of Myocardial Scars on CMR After COVID-19 Infection
NCT ID: NCT04636320
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
231 participants
INTERVENTIONAL
2020-06-13
2022-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patient group COVID-19
120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization
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.
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.
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.
Resting 12 lead ECG
A resting 12 lead ECG will be performed at Day 0 visit.
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.
Healthy volunteer group
120 healthy volunteers. Age- and sex-matched controls
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.
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.
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.
Resting 12 lead ECG
A resting 12 lead ECG will be performed at Day 0 visit.
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.
Interventions
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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.
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.
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.
Resting 12 lead ECG
A resting 12 lead ECG will be performed at Day 0 visit.
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
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Grant Agreement ERC n°715093
UNKNOWN
University of Bordeaux
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Hubert COCHET, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Bordeaux University Hospital
Pessac, , France
Countries
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Other Identifiers
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CHUBX 2020/22
Identifier Type: -
Identifier Source: org_study_id
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