Prevalence of Myocardial Scars on CMR After COVID-19 Infection

COVID-19 Clinical Trial

— COVID-CMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636320
• Other study ID #: CHUBX 2020/22
• Status: Completed
• Phase: N/A
• Start date: June 13, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Virus Disease
• Virus Diseases

Intervention

Device:
• 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.

Diagnostic Test:
• 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.

Biological:
• 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.

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Grant Agreement ERC n°715093, University of Bordeaux - mission UB-C19

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CMR feature : Location and size of myocardial scars	Measured in mL	Day 0
Secondary	CMR feature : native T1 and T2 values	Measured in milliseconds	Day 0
Secondary	CMR feature : extracellular volume fraction	Measured in percentage	Day 0
Secondary	CMR feature : ventricular volumes	Measured in mL/m2	Day 0
Secondary	CMR feature : ejection fraction	Measured in percentage	Day 0
Secondary	CMR feature : myocardial strain	Measured in percentage	Day 0
Secondary	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.	Baseline and month 3
Secondary	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.	Baseline and month 3
Secondary	Biological feature : troponin level	Measured in fg/ml	Day 0
Secondary	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.	Day 0
Secondary	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	Day 0