The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Global cognitive ability
研究概览
简要总结
The goal of this observational study is to learn about neuroimage and biomarkers in the cerebral small vessel disease. The main questions it aims to answer are:
- How does neurovascular coupling change during the progression of CSVD?
- How is the pattern/mapping of alterations in CSVD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.
详细描述
This observational study recruits participants with cerebral small vessel disease (CSVD) from hospitals and community-based populations. Healthy volunteers will also be recruited as controls. Longitudinal follow-up of these participants will help clarify the significance of neuroimaging and biological biomarkers during the development and progression of CSVD.
The investigators aim to establish a longitudinal cohort covering the spectrum of CSVD and identify key biomarkers associated with disease progression and cognitive decline. All participants will undergo multimodal MRI, PET imaging (optional) with different tracers, and blood biomarker assessments. Using multimodal MRI, the investigators will investigate alterations in neurovascular coupling and their role in the pathophysiology of CSVD. In addition, PET imaging (optional) and blood biomarkers will be used to characterize the spatial and temporal patterns of disease-related biomarker changes. Furthermore, additional neuroimaging and digital biomarkers will be evaluated within the cohort to improve disease characterization and prognostic prediction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •Evidence of cerebral small vessel disease (CSVD) on brain MRI, meeting at least one of the following imaging criteria:
- •White matter hyperintensities (WMH) with a total Fazekas score ≥2;
- •Fazekas score =1 with at least two vascular risk factors (hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoking, or a history of vascular events other than stroke);
- •Fazekas score =1 accompanied by the presence of lacunes;
- •Imaging evidence of a recent subcortical lacunar infarction.
- •Independent in activities of daily living (modified Rankin Scale [mRS] ≤2).
- •Able and willing to provide written informed consent.
排除标准
- •Acute ischemic stroke with a diffusion-weighted imaging (DWI) lesion >20 mm in diameter.
- •Acute intracerebral hemorrhage.
- •Acute subarachnoid hemorrhage, a history of aneurysmal subarachnoid hemorrhage or cerebrovascular malformation, or the presence of an untreated intracranial aneurysm >3 mm in diameter.
- •Previously diagnosed neurodegenerative disorders, such as Alzheimer's disease (AD) or Parkinson's disease (PD).
- •Definite non-vascular white matter diseases, including multiple sclerosis, adult-onset leukodystrophy, metabolic encephalopathy, or other non-vascular white matter disorders.
- •Major psychiatric disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •Contraindications to MRI (e.g., severe claustrophobia or MRI-incompatible implants).
- •Severe systemic diseases (e.g., active malignancy) with an expected life expectancy of less than 5 years.
- •Inability to complete scheduled follow-up because of geographic, logistical, or other reasons.
- •Concurrent participation in another interventional clinical trial.
结局指标
主要结局
Global cognitive ability
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Mini-mental state examination
Executive function
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Clock drawing test
Visual memory
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Rey-Osterich complex figure test
Short-term memory
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Auditory verbal learning test
Executive memory
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Symbol-digit test
Spatial executive function
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Trail making test
Naming ability
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Boston naming test
Language ability
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language fluency test
Sleep quality
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep disorder
Movement ability
时间窗: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Part III of the Unified Parkinson's Disease Rating Scale
次要结局
- Brain volume(baseline, 1 year, 2-year, 3-year, 5-year,10-year)
- Connectivity integrity of the neural circuit(baseline, 1 year, 2-year, 3-year, 5-year,10-year)
- Volume of white matter lesions(baseline, 1 year, 2-year, 3-year, 5-year,10-year)