Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study
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: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin, Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin.
- Who it may be relevant to
- Registry conditions: Intracranial Atherosclerosis, Cognitive Impairment, Cerebrovascular Event. Basic parameters: 18 years — 80 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
- China
- 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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Official title
Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study
Overview
The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.
Detailed description
All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.
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.
Interventions
- Drug 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. - Procedure 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.
Primary outcome measures
- The changes in Memory [Time frame: baseline, 3-month and 1-year follow-up]
- Occurrence of ischemic cerebrovascular events [Time frame: baseline, 3-month and 1-year follow-up]
Secondary outcome measures (12)
- MoCA (Montreal Cognitive Assessment) [Time frame: baseline, 3-month and 1-year follow-up]
- MMSE (Mini Mental State Examination) [Time frame: baseline, 3-month and 1-year follow-up]
- DST (Digital Span Test; Forward and Backward) [Time frame: baseline, 3-month and 1-year follow-up]
- The Stroop Color Test [Time frame: baseline, 3-month and 1-year follow-up]
- CTT (Color Trail Test) [Time frame: baseline, 3-month and 1-year follow-up]
- CDT (Clock drawing test) [Time frame: baseline, 3-month and 1-year follow-up]
- VFT (Verbal Fluency Test) [Time frame: baseline, 3-month and 1-year follow-up]
- HAMD (Hamilton Depression Scale) [Time frame: baseline, 3-month and 1-year follow-up]
- HAMA (Hamilton Anxiety Scale) [Time frame: baseline, 3-month and 1-year follow-up]
- MRI measure- resting state MRI images [Time frame: baseline, 3-month and 1-year follow-up]
- MRI measures-structural phase MRI images [Time frame: baseline, 3-month and 1-year follow-up]
- MRI measures-3D pCASL images [Time frame: baseline, 3-month and 1-year follow-up]
Eligibility criteria
Inclusion criteria
- Age between 18 and 80 years
- 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
- Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
- 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
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
- Cohort
Study locations
China · 1 center
- Anhui Medical University — Hefei
Identifiers
NCT: NCT06336174 · Anhui-SIA-cohort