NCT05322824招募中不适用
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Changes in the scores of Mini-mental State Examination
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 40 years
- •≥ 50% stenosis in unilateral intracranial / carotid artery
- •Written informed consent available
排除标准
- •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
结局指标
主要结局
Changes in the scores of Mini-mental State Examination
时间窗: 2 years
Total score of 30. Higher scores mean a better outcome.
次要结局
- 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)
研究者
研究点 (1)
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