Clinical trial
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Name
CHUBX 2020/22
Description
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 arms
Trial start
2020-06-13
Estimated PCD
2022-04-04
Trial end
2022-04-04
Status
Completed
Treatment
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.
Arms:
Healthy volunteer group, Patient group COVID-19
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.
Arms:
Healthy volunteer group, Patient group COVID-19
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.
Arms:
Healthy volunteer group, Patient group COVID-19
Resting 12 lead ECG
A resting 12 lead ECG will be performed at Day 0 visit.
Arms:
Healthy volunteer group, Patient group COVID-19
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.
Arms:
Healthy volunteer group, Patient group COVID-19
Size
231
Primary endpoint
Prevalence of myocardial scars
Day 0
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-centre case-control study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 231, 'type': 'ACTUAL'}}
Updated at
2023-03-16
1 organization
2 indications
Organization
University Hospital BordeauxIndication
COVID-19Indication
Virus Infection