Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DSA/3DRA.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Atheroscleroses, Cerebral. Basic parameters: 30 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD).
Detailed description
Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery will proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators blind to subjects' clinical information. All recruited patients will receive standard medical therapy throughout the investigation period.
Interventions
- Diagnostic test DSA/3DRA
DSA/3DRA
Primary outcome measures
- The plaque morphology of high-risk IAD may be distinct from the silent ones. [Time frame: Dec, 2020]
Eligibility criteria
Inclusion criteria
- Inclusion Criteria for the Symptomatic Group:
- Patient is 30 to 85 years of age, inclusive.
- Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism, a relevant intracranial atherosclerotic stenosis ≥60%, and MES detected by TCD.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient understands the purpose and requirements of the study, and has provided an informed consent.
- Inclusion Criteria for the Asymptomatic Group:
- Patient is 30 to 85 years of age, inclusive.
- Patient who has a high-grade (>60%) intracranial stenosis (signal void in MR angiography) but without infarct in the corresponding vascular territory in DWI or T2-weighted sequence.
- Patient has no MES detected on TCD examination.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient understands the purpose and requirements of the study, and has provided an informed consent.
Exclusion criteria
Subject who meets one or more of the following criteria cannot be recruited in the study:
- Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
- A tandem stenosis >50% at proximal internal carotid artery.
- Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).
- A medical condition that would not allow the patient to adhere to the protocol or complete the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Hong Kong · 1 center
- Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT03291652 · crec no. 2011.021