NCT04318119

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
359mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Nov 2019Nov 2055

Study Start

First participant enrolled

November 18, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
29.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2049

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2055

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

30 years

First QC Date

March 14, 2020

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall outcomes in patients with cerebral small vessel disease.

    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 Outcomes (4)

  • the development of the burden of microbleeds in MRI

    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

    From date of enrollment until the date of death from any cause, assessed up to 30 years

  • the development of lacunes in MRI

    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

    From date of enrollment until the date of death from any cause, assessed up to 30 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who are diagnosed as Cerebral Small Vessel Disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology , First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Bin Cai, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 23, 2020

Study Start

November 18, 2019

Primary Completion (Estimated)

November 18, 2049

Study Completion (Estimated)

November 18, 2055

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations