China Imaging-based Biobank of Cerebral Small Vessal Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Small Vessel Diseases
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Xiaogang Li; Phone Number: 13501095002; Email: bysy@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cerebral Small Vessal Diseases patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cerebral Small Vessel Diseases group; CSVD patients	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with each diagnosis.	Detailed diagnosis of the patient's disease.	At discharge, usually within two weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS score	mRS score of patients	during 5 years after diagnosis
New adverse vascular events	New adverse vascular events	during 5 years after diagnosis

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases
• Other Study ID Numbers: M2021248

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No