Cerebral Small Vessel Disease Registry Study

September 26, 2023 updated by: Bin Cai
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • Recruiting
        • Department of Neurology , First Affiliated Hospital Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient who are diagnosed as Cerebral Small Vessel Disease

Description

Inclusion Criteria:

  1. Sign informed consent.
  2. Age>18
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of enrollment until the date of death from any cause, assessed up to 30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
using Fazakes scale to evaluate the development of the burden of white matter hypertension
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
record the number and location of lacunes
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
record the number and location of enlarged perivascular space
From date of enrollment until the date of death from any cause, assessed up to 30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bin Cai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Estimated)

November 18, 2049

Study Completion (Estimated)

November 18, 2055

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH of FMU [2019]245

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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