Correlation Between Deep Medullary Veins and Cognitive Dysfunction in Cerebral Small Vessel Disease

NCT05715710 | Recruiting

• 1 other identifier: 2022ZCNKY08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to obtain the characteristics of cognitive impairment and imaging characteristics of patients with Cerebral small vessel disease (CSVD) through comprehensive and standardized neuropsychological assessment and multimodal imaging examination. The focus is to obtain the characteristics of cognitive impairment and imaging characteristics of patients with CSVD through 3.0T MRI SWI sequence. deep medullary veins (DMVs) were measured. To compare the demographic data, hematological indexes, imaging scores and the number of DMVs between CSVD groups with and without cognitive impairment, and to explore the correlation between deep medullary veins and cognitive dysfunction in cerebral small vessel disease.

Conditions

Cerebral Small Vessel Disease

Keywords

deep medullary veins; csvd; cerebral small vessel disease

Outcome Measures

Primary Outcomes (1)

• Deep medullary veins score

  In this study, deep medullary veins (DMVs) were counted by SWI sequence.

  2022.01-2025.1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. CSVD patients who met the inclusion and exclusion criteria were included. Demographic data, cerebrovascular disease risk factors data, and hematological data were collected. 2. Standardized neuropsychological assessment was performed to evaluate the general cognition and various cognitive domains (memory, language, visuospatial execution) of CSVD patients. 3. Fazekas score of white matter hyperintensity (WMH) and cerebral microbleed (cerebral microbleed) were calculated based on the results of 3.0 T multimode MRI examination. CMB count, lacunar infarction count, perivascular space (PVS) count, and MRI total load score; Deep medullary veins (DMVs) were counted by SWI sequence.

You may qualify if:

• Age 50 \~ 85 years old.
• The diagnostic criteria of CSVD patients with cerebral small vessel diseases should be in accordance with the 2015 Chinese Consensus on the diagnosis and treatment of cerebral small vessel Diseases formulated and recommended by the Cerebrovascular Division of Chinese Society of Neurology, Chinese Medical Association. MRI examination revealed the presence of one or more of the major imaging features of CSVD as proposed by the 2013 International Standards Reporting Group on Neuroimaging of Vascular Changes.
• No large vessel stenosis (stenosis rate \> 50%) was found after head and neck vascular examination (CTA, MRA, DSA or TCD combined with carotid ultrasound).
• The vital signs are stable and can cooperate with the examination.
• Informed consent signed by the patient or legal representative.

You may not qualify if:

• Cerebral infarction or cerebral hemorrhage caused by large vascular disease; And CTA/MRA of the head and neck showed great vessel stenosis (stenosis rate \> 50%).
• Patients with secondary white matter lesions caused by poisoning, inflammation, tumor and other pathological changes.
• Cognitive impairment and gait impairment caused by other causes (such as Alzheimer's disease, Parkinson's disease, depression, etc.
• Patients with contraindications of magnetic resonance examination.
• Illiterate or unable to cooperate with cognitive assessment due to severe hearing and visual impairment.

Sponsors & Collaborators

• Zigong No.1 Peoples Hospital: lead

Study Sites (1)

Zigong First People's Hospital

Zigong, Sichuan, 643000, 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 Officials

• ya x Xu

  Zigong No.1 People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ya x Xu

CONTACT

15983171312; 502687651@qq.com

ling zhao

CONTACT

13679076409; 1628583742@qq.com

Study Design

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

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)