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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT05583305
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with APS who fulfilled the modified Sapporo criteria:
1. at least one clinical criterion (vascular thrombosis or pregnancy morbidity); and
2. laboratory criteria (aPL positivity twice, 12 weeks apart):
i. Lupus anticoagulant positivity requires screening, mixing, and confirmation test as per International Society of Thrombosis and Hemostasis guidelines (11). ii. Anticardiolipin antibodies positivity requires a medium to high titer IgG and/or IgM level by ELISA assays. iii. Anti-β2 glycoprotein antibodies positivity requires a \>99th titer IgG and/or IgM level by ELISA assays.
2. Patients age ≥18 years
3. Patients who are able to provide an informed consent to study procedures
Exclusion Criteria:
1. Patient with established neurological disease, such as stroke, cerebral venous thrombosis, vasculitis of the central nervous system, cerebral lupus, etc.
2. Patient contraindicated to contrast MRI scans. E.g. claustrophobia, allergy to gadolinium contrast, MRI incompatible implants, estimated glomerular filtration rate of \< 30mL/min/1.73m2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05583305
Study Brief:
Protocol Section:
NCT05583305