Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Recruiting

• Conditions: Cognitive Function; Stenosis

• Registration Number: NCT05322824
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-10
• Study First Posted: 2022-04-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the scores of Mini-mental State Examination	2 years	Total score of 30. Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
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	Total score of 30
Changes in the scores of Olfactory stick test	2 years
Changes in metabonomics	2 years	include blood and fecal samples
Incidence of stroke event including ischemic and hemorrhagic stroke	2 years
Changes in cerebral glymphatic function	2 years	assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Changes in cerebral blood flow in the territory of the culprit artery	2 years
Changes in the scores of Colour Trail Test	2 years

Trial Locations

Locations (1)

Second Affilated Hospital of Zhejiang University, School of Medicine; 🇨🇳 HangZhou, Zhejiang, China