The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital
21 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
400
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200025
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Contacto:
- Jingyan Tian, Dr
- Número de teléfono: 13671865057
- Correo electrónico: tjy11488@rjh.com.cn
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Investigador principal:
- Jingwen Jiang, Dr.
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Sub-Investigador:
- Binyin Li, Dr.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Global cognitive ability
Periodo de tiempo: 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
Periodo de tiempo: baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Clock drawing test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
|
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Visual memory
Periodo de tiempo: 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
Periodo de tiempo: baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Auditory verbal learning test
|
baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Executive memory
Periodo de tiempo: baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Symbol-digit test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Spatial executive function
Periodo de tiempo: baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Trail making test
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Naming ability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Part III of the Unified Parkinson's Disease Rating Scale
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baseline, 1 year, 2-year, 3-year, 5-year,10-year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brain volume
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
8 de julio de 2026
Finalización primaria (Estimado)
30 de septiembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RJNeuroBank-SVD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
There is not yet a plan to make IPD available to other researchers
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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