Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study
NCT ID: NCT06336174
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-11-01
2026-12-31
Brief Summary
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Detailed Description
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About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.
After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgery Group
Symptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment
Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
All patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Medical group
Symptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy
Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Interventions
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Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
All patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Eligibility Criteria
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Inclusion Criteria
* Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
* Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale \[NIHSS\] score ≤ 4 points)
* Right-handed and able to cooperate in neuropsychological tests
* At least 14 days post-onset of cerebral infarction or TIA
* Signed informed consent
Exclusion Criteria
* Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
* More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
* Vasculitis, moyamoya disease, and cardiogenic stroke
* Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries
18 Years
80 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Head of Neurology, Principal Investigator，Clinical Professor
Locations
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Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Anhui-SIA-cohort
Identifier Type: -
Identifier Source: org_study_id
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