China Imaging-based Biobank of Cerebral Small Vessal Diseases

Cerebral Small Vessel Diseases Clinical Trial

Official title:

China Imaging-based Biobank of Cerebral Small Vessal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962295
• Other study ID #: M2021248
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to build a national image-based comprehensive evaluation platform of CSVD through longitudinal collection of imaging based medical data of patients with cerebral small vessel diseases (CSVD). On this basis, the new classification and diagnostic criteria of CSVD are proposed, and the risk prediction model of CSVD is established. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population.

Description:

The purpose of this study is to build a national image-based CSVD comprehensive evaluation platform by collecting the medical data of patients with cerebral small vessel diseases (CSVD) based on imaging longitudinally, and to evaluate the risk factors of each type of CSVD, as well as imaging signs, cognition, gait, autonomic nervous system and hemodynamics, sleep, sleep, and so on The outcome of emotion and fundus. In the fields of imaging, molecular and neurocognitive function, we explored the etiology and pathophysiological mechanism of CSVD, proposed new classification and diagnostic criteria of CSVD, and established the risk prediction model of CSVD. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population, in order to reduce the burden of CSVD in China in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old

2. SVD lesions can be seen on MRI of the head

• White matter hyperintensity, Fazekas score = 2

• Fazekas=1 has more than 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, smoking, and other vascular events except stroke).

• Fazekas = 1 and combined with lacunar focus

• Imaging findings suggest new subcortical lacunar infarction

3. Daily life independence (MRS = 2)

4. Sign informed consent

Note: the imaging definition of small vessel disease refers to the strong guideline

1. The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.

2. New subcortical lacunar infarction: head MRI examination, subcortical, basal ganglia or brain stem DWI showed high signal (ADC diffusion limited) lesions with diameter < 20 mm, with or without corresponding clinical symptoms; There were new clinical symptoms. FLAIR sequence of head MRI showed flair hyperintense lesions (diameter < 20 mm) in subcortical, basal ganglia or pons.

Exclusion Criteria:

1. In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm

2. Acute cerebral hemorrhage

3. Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,

Or untreated aneurysms (> 3mm in diameter) were found

4. Neurodegenerative diseases, such as AD and PD, have been diagnosed

5. There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy

Diseases, etc

6. Mental disorders diagnosed according to DSM-V diagnostic criteria

7. Contraindications of MRI examination (such as claustrophobia)

8. With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years

9. Due to geographical or other reasons can not cooperate to complete the follow-up

10. Patients also participated in other clinical trials

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with each diagnosis.	Detailed diagnosis of the patient's disease.	At discharge, usually within two weeks.
Secondary	mRS score	mRS score of patients	during 5 years after diagnosis
Secondary	New adverse vascular events	New adverse vascular events	during 5 years after diagnosis