Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 18, 2023
March 1, 2023
6 years
April 1, 2022
April 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the scores of Mini-mental State Examination
Total score of 30. Higher scores mean a better outcome.
2 years
Secondary Outcomes (10)
Incidence of stroke event including ischemic and hemorrhagic stroke
2 years
Changes in cerebral glymphatic function
2 years
Changes in the scores of Montreal Cognitive Assessment
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
- +5 more secondary outcomes
Interventions
standard medical treatment
Interventional stenting
Eligibility Criteria
Patients with intracranial / carotid stenosis aged ≥ 40 years
You may qualify if:
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 12, 2022
Study Start
January 1, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
April 18, 2023
Record last verified: 2023-03