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

Sponsor
Zigong No.1 Peoples Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05715710
Collaborator
(none)
200
1
44
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study aims to obtain the characteristics of cognitive impairment and imaging characteristics of patients with Cerebral small vessel disease (CSVD) by conducting comprehensive and standardized neuropsychological assessment and multimodal imaging examination. deep medullary veins (DMVs) were measured. The demographic data, hematological indexes, imaging scores and the number of DMVs were compared between the CSVD group with and without cognitive impairment, and the risk factors for cognitive impairment in CSVD were analyzed to explore whether DMVs could be an independent risk factor for cognitive impairment in CSVD. To establish a multiple model for the risk prediction of cognitive impairment in CSVD, and to understand whether the prediction model combined with the number of DMVs has a better prediction effect on cognitive impairment in CSVD. In order to find new imaging markers of cognitive impairment in CSVD, and provide evidence for early detection and intervention of cognitive impairment in clinical CSVD.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Deep Medullary Veins and Cognitive Dysfunction in Cerebral Small Vessel Disease
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Deep medullary veins score [2022.01-2025.1]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    1. Inclusion Criteria

    2. Age 50 ~ 85 years old.

    3. 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.

    4. No large vessel stenosis (stenosis rate > 50%) was found after head and neck vascular examination (CTA, MRA, DSA or TCD combined with carotid ultrasound).

    5. The vital signs are stable and can cooperate with the examination.

    6. Informed consent signed by the patient or legal representative.

    7. Exclusion Criteria:

    8. 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%).

    9. Patients with secondary white matter lesions caused by poisoning, inflammation, tumor and other pathological changes.

    10. Cognitive impairment and gait impairment caused by other causes (such as Alzheimer's disease, Parkinson's disease, depression, etc.

    11. Patients with contraindications of magnetic resonance examination.

    12. Illiterate or unable to cooperate with cognitive assessment due to severe hearing and visual impairment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zigong First People's Hospital Zigong Sichuan China 643000

    Sponsors and Collaborators

    • Zigong No.1 Peoples Hospital

    Investigators

    • Principal Investigator: ya x Xu, Zigong No.1 People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zigong No.1 Peoples Hospital
    ClinicalTrials.gov Identifier:
    NCT05715710
    Other Study ID Numbers:
    • 2022ZCNKY08
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zigong No.1 Peoples Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2023