Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05583305 |
Other study ID # |
CREC 2022.352 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 12, 2022 |
Est. completion date |
July 17, 2026 |
Study information
Verified date |
May 2024 |
Source |
Chinese University of Hong Kong |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
Upon reviewing the clinical and laboratory information in the medical specialist out-patient
clinics, electronic patient record and/or through the Clinical Data Analysis And Reporting
System (CDARS), investigators shall identify and recruit on-site APS patients who fulfilled
the modified Sapporo criteria, currently aged ≥18 years, and receive care from the Prince of
Wales Hospital.
Investigators shall then arrange a study clinic visit for eligible patients. After obtaining
an informed consent, patients will be subjected to cognitive assessment (Hong Kong Version of
Montreal Cognitive Assessment (HK-MoCA)), blood pressure, pulse, body mass index measurement,
urinalysis, and contrast MRI brain (see imaging assessment below). Demographic data (age,
gender, smoking, drinking, ambulatory status), medical comorbidities (concurrent autoimmune
diseases and their organ involvement, history of catastrophic APS, hypertension,
hyperlipidemia, diabetes mellitus, congestive heart failure, number and type of previous
arterial or venous thromboembolism), laboratory parameters (complete blood count, liver and
renal function test, C-reactive protein, erythrocyte sediment rate, high sensitive C-reaction
protein, plasminogen activator inhibitor-1, neurofilament light chain, titers of autoimmune
markers including anti-nuclear antibodies, extractable nuclear antigen antibodies, aPLs,
rheumatoid factor, anti-cyclic citrullinated peptide antibody, etc.), concurrent medications
(aspirin, warfarin, direct oral anticoagulants, antihypertensives, statins, steroid,
immunosuppressants, etc.). In another ongoing prospective Brain Health Longitudinal study
which contained stroke- and dementia free participants (CREC Ref. No: 2018.148),
investigators shall identify age- and gender-matched individuals without aPLs as controls.
They will be assessed in the same manner as the APS patients.