NCT05985213招募中不适用
Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Shanghai Yueyang Integrated Medicine Hospital1 个研究点 分布在 1 个国家目标入组 1,078 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,078
- 试验地点
- 1
- 主要终点
- Cognitive state
研究概览
简要总结
This cohort study involves the dynamic collection of clinical information, including serum parameters , blood pressure variability, imaging data, and neuropsychological scales, in patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical and imaging characteristics of the CSVD population and identify novel CSVD risk factors. Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood disorders in patients with CSVD will be established.
详细描述
Research Objectives:
- To conduct a longitudinal study on patients with cerebral small vessel disease (CSVD) and observe the dynamic evolution of their cognitive functioning, emotional disorders, and other related factors.
- To explore and summarize the clinical and radiological characteristics of the CSVD population, and identify new risk factors for CSVD.
- To investigate in depth the underlying mechanisms and the relationship between clinical and radiological outcomes in CSVD.
- To establish a multifactor prediction model for cognitive and emotional disorders in CSVD.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged between 18 and 80 years, with no restriction on gender.
- •Participants who have completed a 3.0T MRI of the head within one year at Yueyang Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.
- •Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform activities of daily living) at the time of the visit.
- •Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.
排除标准
- •Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can be enrolled after 6 months to avoid the impact of the acute phase).
- •Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.
- •Imaging data reveals intracranial space-occupying lesions.
- •A history of other neurological or mental illnesses with a definite diagnosis of the cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases (such as Parkinson's disease and Alzheimer's disease).
- •Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
- •Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
- •Women who are pregnant or breastfeeding.
- •MRI scan contraindicated due to various reasons (such as claustrophobia).
- •Any other reasons that prevent the collection of clinical data required for this study.
结局指标
主要结局
Cognitive state
时间窗: 2020-12-1 to 2027-12-31
The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.
次要结局
- Blood pressure variability(2020-12-1 to 2027-12-31)
- The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.(2020-12-1 to 2027-12-31)
研究者
研究点 (1)
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