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Clinical Trials/NCT05322824
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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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