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:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04936503
Eligibility Criteria:
Inclusion Criteria:
* High level athlete,
* Of both sexes and age ≥ 18 years,
* Affiliated to or beneficiary of a social security system,
* Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research),
* Effective method of contraception for women with childbearing capacity.
Exclusion Criteria:
* Minor,
* History of ventricular arrhythmia, myocarditis, identified coronary artery disease or documented myocardial fibrosis,
* Pregnant or breastfeeding women,
* Person unable to give informed consent,
* Person deprived of liberty by judicial or administrative decision,
* Adults subject to a legal protection measure (guardianship, curator, safeguard of justice).
Specific exclusion criteria for the MRI component (Contraindications):
* Subject with an implantable pacemaker or defibrillator, intraocular metallic foreign body, intracranial metallic clip, pre 6000 Starr-Edwards type cardiac valve prosthesis, or biomedical device such as insulin pump or neurostimulator,
* Hypersensitivity to gadolinium or to one of the excipients of the contrast product used,
* Claustrophobic subjects or those unable to remain in an immobile lying position for 30 minutes,
* Renal insufficiency with creatinine clearance of less than 30 ml/min,
* A patient whose shoulder width does not allow installation in the MRI machine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04936503
Study Brief:
Protocol Section:
NCT04936503