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The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

21 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Maladie des petits vaisseaux cérébraux

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Chine
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Chine, 200025
    - Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    - Contact:
      
      Jingyan Tian, Dr
      
      Numéro de téléphone: 13671865057
      
      E-mail: tjy11488@rjh.com.cn
    - Chercheur principal:
      
      Jingwen Jiang, Dr.
    - Sous-enquêteur:
      
      Binyin Li, Dr.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Cognitively Normal Participants do not have cognitive impairment.
Cerebral small vessel disease without dementia Participants have vascular cognitive impairment, but no cognitive impairment
Vascular Dementia (VaD) Participants have vascular cognitive impairment or difficulty in daily activity.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Global cognitive ability Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Mini-mental state examination	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive function Délai: 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 Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Rey-Osterich complex figure test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Short-term memory Délai: 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
Executive memory Délai: 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
Spatial executive function Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Trail making test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Naming ability Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Boston naming test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language ability Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Language fluency test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep quality Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Sleep disorder	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Movement ability Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Brain volume Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of volumes of brain	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Connectivity integrity of the neural circuit Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of hippocampus related neural connectivity	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Volume of white matter lesions Délai: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).	baseline, 1 year, 2-year, 3-year, 5-year,10-year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ruijin Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 juillet 2026

Achèvement primaire (Estimé)

30 septembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

10 juillet 2026

Première soumission répondant aux critères de contrôle qualité

21 juillet 2026

Première publication (Réel)

24 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)