China Imaging-based Biobank of Cerebral Small Vessal Diseases

NCT04962295 | Recruiting

• 1 other identifier: M2021248
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (1)

• The number of patients with each diagnosis.

  Detailed diagnosis of the patient's disease.

  At discharge, usually within two weeks.

Secondary Outcomes (2)

• mRS score

  during 5 years after diagnosis

• New adverse vascular events

  during 5 years after diagnosis

Study Arms (1)

Cerebral Small Vessel Diseases group

CSVD patients

Other: No intervention

Interventions

No intervention OTHER

No intervention

Cerebral Small Vessel Diseases group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cerebral Small Vessal Diseases patients

You may qualify if:

• Age ≥ 18 years old
• 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
• Daily life independence (MRS ≤ 2)
• Sign informed consent
• Note: the imaging definition of small vessel disease refers to the strong guideline
• The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.
• 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.

You may not qualify if:

• In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm
• Acute cerebral hemorrhage
• Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,
• Or untreated aneurysms (\> 3mm in diameter) were found
• Neurodegenerative diseases, such as AD and PD, have been diagnosed
• There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy
• Diseases, etc
• Mental disorders diagnosed according to DSM-V diagnostic criteria
• Contraindications of MRI examination (such as claustrophobia)
• With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years
• Due to geographical or other reasons can not cooperate to complete the follow-up
• Patients also participated in other clinical trials

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 14, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 14, 2021

Record last verified: 2021-06

Locations

CN (1)