Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04636320
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Myocardial Scars on CMR After COVID-19 Infection
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-CMR
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: