Bordeaux University Hospital
Pessac, 33604, France
NCT Number: NCT04636320
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pessac, 33604, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0
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
Measured in mL
Time frame: Day 0
Measured in milliseconds
Time frame: Day 0
Measured in percentage
Time frame: Day 0
Measured in mL/m2
Time frame: Day 0
Measured in percentage
Time frame: Day 0
Measured in percentage
Time frame: Baseline and month 3
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
Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes.
Measured in percentage.
Time frame: Day 0
Measured in fg/ml
Time frame: Day 0
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
Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19
University Hospital, Bordeaux
Other
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Acronym: COVID-CMR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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