Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome

Enrolling by invitation

Conditions studied: Antiphospholipid Syndrome, Stenosis, Intracranial Stenosis

In brief

Antiphospholipid syndrome (APS) is an important cause of young stroke which could result in major disability. Cohort studies suggested that 17% of young ischemic stroke were accountable by APS (1). Although warfarin has been the mainstay of treatment in APS for the past decades, recurrent thromboembolism occurred up to 10% of warfarinized patients with APS (2, 3). These observations call for an in-depth understanding of disease mechanisms secondary to antiphospholipid antibodies (aPL). Contrary to traditional understanding, recent evidence suggested mechanisms of cerebrovascular ischemia in APS are far more complex than hypercoagulability alone. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS.

Key facts

Study ID

NCT05583305

Run by

Chinese University of Hong Kong

People needed

60

Starts

2022-10-12

Expected to finish

2027-07-17

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with APS who fulfilled the modified Sapporo criteria:
• at least one clinical criterion (vascular thrombosis or pregnancy morbidity); and
• 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.
• Patients age ≥18 years
• Patients who are able to provide an informed consent to study procedures

You may not qualify if…

• Patient with established neurological disease, such as stroke, cerebral venous thrombosis, vasculitis of the central nervous system, cerebral lupus, etc.
• 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.

Where it is running

• Chinese University of Hong Kong — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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