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Recruiting NCT04318119

Cerebral Small Vessel Disease Registry Study

— Observational Cerebral Small Vessel Diseases

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 Diseases. Basic parameters: 18 years — 100 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 →

Unsure about the terms? Read our patient guide →

Overview

The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.

Primary outcome measures

  • Overall outcomes in patients with cerebral small vessel disease. [Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years]
Secondary outcome measures (4)
  • the development of the burden of microbleeds in MRI [Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years]
  • the development of the burden of white matter hypertension in MRI [Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years]
  • the development of lacunes in MRI [Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years]
  • the development of enlarged perivascular space in MRI [Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years]

Eligibility criteria

Inclusion criteria

  • Sign informed consent.
  • Age>18
  • At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy

Exclusion criteria

  • Unable to cooperate with inspectors
  • Non-vascular white matter lesions
  • Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
  • Serious systemic illness, such as heart, liver, kidney disease or major mental illness
  • Contraindications for imaging examination

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurology , First Affiliated Hospital Fujian Medical University — Fuzhou

Publications

  • Hu F, Xie W, Fan M, Wang Y, Xu S, Qiu W, Yang T, Lv H, Huang H, Wu Y, Fu Y, Cai B. Intracerebral Hemorrhage in Autosomal Dominant Cerebral Arteriopathy With Subcortical Infarcts and Leukoencephalopathy. Eur J Neurol. 2025 Mar;32(3):e70100. doi: 10.1111/ene.70100. PMID 40067051

Identifiers

NCT: NCT04318119 · MRCTA,ECFAH of FMU [2019]245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗