Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
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: standard medical treatment, Interventional stenting.
- Who it may be relevant to
- Registry conditions: Cognitive Function, Stenosis. Basic parameters: from 40 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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Overview
Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.
Interventions
- Drug standard medical treatment
standard medical treatment - Procedure Interventional stenting
Interventional stenting
Primary outcome measures
- Changes in the scores of Mini-mental State Examination [Time frame: 2 years]
Secondary outcome measures (10)
- Incidence of stroke event including ischemic and hemorrhagic stroke [Time frame: 2 years]
- Changes in cerebral glymphatic function [Time frame: 2 years]
- Changes in the scores of Montreal Cognitive Assessment [Time frame: 2 years]
- Changes in cerebral blood flow in the territory of the culprit artery [Time frame: 2 years]
- Changes in the scores of Colour Trail Test [Time frame: 2 years]
- Changes in the scores of Hopkins Verbal Learning Test [Time frame: 2 years]
- Changes in the scores of clock drawing test [Time frame: 2 years]
- Changes in the scores of Animal Fluency Test [Time frame: 2 years]
- Changes in the scores of Olfactory stick test [Time frame: 2 years]
- Changes in metabonomics [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
Exclusion criteria
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
Exit Criteria:
- Not meet the inclusion criteria
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
- Any adverse or serious adverse events during the study period judged by investigator
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
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou
Identifiers
NCT: NCT05322824 · ROSE