Cerebral Small Vessel Disease Registry Study

Cerebral Small Vessel Diseases Clinical Trial

Official title:

Cerebral Small Vessel Disease Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318119
• Other study ID #: MRCTA,ECFAH of FMU [2019]245
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: November 18, 2055

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Bin Cai, PhD
• Phone: 13338413842
• Email: caibin929[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 18, 2055
• Est. primary completion date: November 18, 2049
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Sign informed consent.

2. Age>18

3. At least one of the following CSVD MRI characteristics: ?recent small subcortical infarct;?lacune of presumed vascular origin;?white matter hypertensity of presumed vascular origin;?perivascular space;?cerebral microbleeds;?brain 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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Locations

Country	Name	City	State
China	Department of Neurology , First Affiliated Hospital Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Bin Cai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the development of the burden of microbleeds in MRI	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
Secondary	the development of the burden of white matter hypertension in MRI	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
Secondary	the development of lacunes in MRI	record the number and location of lacunes	From date of enrollment until the date of death from any cause, assessed up to 30 years
Secondary	the development of enlarged perivascular space in MRI	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