Status:
COMPLETED
Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Antiphospholipid Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03348306
Start Date
July 20 2018
End Date
January 14 2022
Last Update
February 3 2022
Active Locations (1)
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1
CHRU Nancy Brabois
Nancy, France, 54000