Cerebral Small Vessel Disease Registry Study

Recruiting

• Conditions: Cerebral Small Vessel Diseases

• Registration Number: NCT04318119
• Lead Sponsor: Bin Cai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2049-11-18
• Study Completion: 2055-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall outcomes in patients with cerebral small vessel disease.	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 Outcome Measures

Name	Time	Method
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	using MARS scale to evaluate the development of the burden of microbleeds
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	record the number and location of enlarged perivascular space
the development of lacunes in MRI	From date of enrollment until the date of death from any cause, assessed up to 30 years	record the number and location of lacunes
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	using Fazakes scale to evaluate the development of the burden of white matter hypertension

Trial Locations

Locations (1)

Department of Neurology , First Affiliated Hospital Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China