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Not yet recruiting NCT07726654

The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

— Observational Cerebral Small Vessel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Small Vessel Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Primary outcome measures

  • Global cognitive ability [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Executive function [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Visual memory [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Short-term memory [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Executive memory [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Spatial executive function [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Naming ability [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Language ability [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Sleep quality [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Movement ability [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
Secondary outcome measures (3)
  • Brain volume [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Connectivity integrity of the neural circuit [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Volume of white matter lesions [Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07726654 · RJNeuroBank-SVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗