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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03348306
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years,
* Patients with documented primary thrombotic and / or obstetrical APS that respond to the revised Sapporo-Sydney classification criteria
* Person affiliated to a social security insurance,
* Person who have received complete information about the organization of the research and have signed informed consent,
* Person who has carried out a suitable clinical examination prior to the research.
Exclusion Criteria:
* Personal history of myocardial infarction, ischemic stroke or severe renal insufficiency,
* Patients with a contraindication to MRI: in particular implantable cardiac pacemakers or defibrillators, implanted pumps, cochlear implants, neurosurgical clips, intraorbital or brain metallic foreign material,
* Impossibility to perform the MRI examination, especially claustrophobic patients, or with a morphotype that does not allow access to MRI (abdominal diameter too large),
* Patient with a contraindication to Gadolinium injection: severe renal insufficiency, allergy to Gadolinium salts (precautions for use in patients at high risk of convulsions),
* APS associated with autoimmune disease (systemic lupus erythematosus according to American College of Rheumatology criteria),
* Patient with known microalbuminuria \> 30mg/L,
* Women of childbearing age who do not have effective contraception,
* Persons referred to in Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the French Public Health Code :
* Pregnant, parturient or nursing mother
* Person deprived of liberty by judicial or administrative decision
* Person undergoing psychiatric care
* Person admitted to a health or social institution for other purposes than research
* Minor person (not emancipated)
* A major person under a measure of legal protection (guardianship, curator, safeguard of justice)
* Person in an emergency situation
* A major person who is unable to express his / her consent and is not under a juridical protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03348306
Study Brief:
Protocol Section:
NCT03348306