Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Second Affiliated Hospital, School of Medicine, Zhejiang University500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Cognitive Function Stenosis

Interventions

standard medical treatmentDRUG

standard medical treatment

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Changes in the scores of Mini-mental State Examination

Total score of 30. Higher scores mean a better outcome.

Time frame: 2 years

Secondary Outcomes

Incidence of stroke event including ischemic and hemorrhagic stroke

Time frame: 2 years

Changes in cerebral glymphatic function

assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

Time frame: 2 years

Changes in the scores of Montreal Cognitive Assessment

Total score of 30

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

include blood and fecal samples

Time frame: 2 years

Data from ClinicalTrials.gov

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Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts