NCT05322824RecruitingNot Applicable
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country500 target enrollmentStarted: January 1, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Changes in the scores of Mini-mental State Examination
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in the scores of Mini-mental State Examination
Time Frame: 2 years
Total score of 30. Higher scores mean a better outcome.
Secondary Outcomes
- Changes in the scores of Hopkins Verbal Learning Test(2 years)
- Changes in the scores of clock drawing test(2 years)
- Changes in the scores of Animal Fluency Test(2 years)
- Changes in the scores of Montreal Cognitive Assessment(2 years)
- Changes in the scores of Olfactory stick test(2 years)
- Changes in metabonomics(2 years)
- Incidence of stroke event including ischemic and hemorrhagic stroke(2 years)
- Changes in cerebral glymphatic function(2 years)
- Changes in cerebral blood flow in the territory of the culprit artery(2 years)
- Changes in the scores of Colour Trail Test(2 years)
Investigators
Study Sites (1)
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