Prevalence of Myocardial Scars on CMR After COVID-19 Infection

NCT04636320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

Interventions

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Grant Agreement ERC n°715093

    collaborator UNKNOWN
  • University of Bordeaux

    collaborator OTHER
  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Hubert COCHET, MD-PhD · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-13
Primary Completion
2022-04-04
Completion
2022-04-04

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636320 on ClinicalTrials.gov