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NCT Number: NCT05715710

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zigong First People's Hospital

Zigong, Sichuan, 643000, China

Location status: Recruiting

Location contact

Hui Li

SUB_INVESTIGATOR

Jing Yang

SUB_INVESTIGATOR

Ling Zhao

SUB_INVESTIGATOR

ya x Xu

CONTACT

[email protected]

15983171312

ya x Xu

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria:
  • 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.

Treatment and study plan

Primary outcomes

  1. Deep medullary veins score

    Time frame: 2022.01-2025.1

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

Study contacts

Contact information is provided by the study sponsor or research team.

ling zhao

CONTACT

[email protected]

13679076409

ya x Xu

CONTACT

[email protected]

15983171312

Sponsors and collaborators

Lead sponsor

Zigong No.1 Peoples Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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