The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200025
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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コンタクト：
- Jingyan Tian, Dr
- 電話番号：13671865057
- メール：tjy11488@rjh.com.cn
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主任研究者：
- Jingwen Jiang, Dr.
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副調査官：
- Binyin Li, Dr.
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Cognitively Normal
Participants do not have cognitive impairment.
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Cerebral small vessel disease without dementia
Participants have vascular cognitive impairment, but no cognitive impairment
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Vascular Dementia (VaD)
Participants have vascular cognitive impairment or difficulty in daily activity.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global cognitive ability
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Mini-mental state examination
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Executive function
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
Clock drawing test
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
|
Visual memory
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
Rey-Osterich complex figure test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Short-term memory
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
Auditory verbal learning test
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Executive memory
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
Symbol-digit test
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Spatial executive function
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Trail making test
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Naming ability
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Boston naming test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Language ability
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Language fluency test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Sleep quality
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Sleep disorder
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Movement ability
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
Part III of the Unified Parkinson's Disease Rating Scale
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Brain volume
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Annual changes of volumes of brain
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Connectivity integrity of the neural circuit
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Annual changes of hippocampus related neural connectivity
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Volume of white matter lesions
時間枠：baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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