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NCT Number: NCT04318119

Cerebral Small Vessel Disease Registry Study

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.

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Key information

Conditions

Cerebral Small Vessel Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology , First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350004, China

Location status: Recruiting

Location contact

Cai Bin

CONTACT

[email protected]

13338413842 ext. 86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

Secondary outcomes

  1. 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

    using MARS scale to evaluate the development of the burden of microbleeds

  2. 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

    using Fazakes scale to evaluate the development of the burden of white matter hypertension

  3. 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

    record the number and location of lacunes

  4. 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

    record the number and location of enlarged perivascular space

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Cai, PhD

CONTACT

[email protected]

13338413842 ext. 86

Sponsors and collaborators

Lead sponsor

Bin Cai

Other

Registry information

Important dates

Study start
2019
Primary completion
2049
Study completion
2055
First posted
Mar 23, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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