Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT04636320
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04636320
Study Brief:
Protocol Section:
NCT04636320