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

February 4, 2023 updated by: Zigong No.1 Peoples Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Zigong, Sichuan, China, 643000
        • Recruiting
        • Zigong First People's Hospital
        • Sub-Investigator:
          • Ling Zhao
        • Contact:
        • Principal Investigator:
          • ya x Xu
        • Sub-Investigator:
          • Jing Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

  1. Inclusion Criteria

    1. Age 50 ~ 85 years old.
    2. 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.
    3. No large vessel stenosis (stenosis rate > 50%) was found after head and neck vascular examination (CTA, MRA, DSA or TCD combined with carotid ultrasound).
    4. The vital signs are stable and can cooperate with the examination.
    5. Informed consent signed by the patient or legal representative.

  2. Exclusion Criteria:

    1. 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%).
    2. Patients with secondary white matter lesions caused by poisoning, inflammation, tumor and other pathological changes.
    3. Cognitive impairment and gait impairment caused by other causes (such as Alzheimer's disease, Parkinson's disease, depression, etc.
    4. Patients with contraindications of magnetic resonance examination.
    5. Illiterate or unable to cooperate with cognitive assessment due to severe hearing and visual impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep medullary veins score
Time Frame: 2022.01-2025.1
In this study, deep medullary veins (DMVs) were counted by SWI sequence.
2022.01-2025.1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zigong No.1 Peoples Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2025

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 4, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022ZCNKY08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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