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

Cerebral Small Vessel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715710
• Other study ID #: 2022ZCNKY08
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2023
• Source: Zigong No.1 Peoples Hospital
• Contact: ya x Xu
• Phone: 15983171312
• Email: 502687651[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Disease
• Cerebral Small Vessel Diseases
• Cognitive Dysfunction

Locations

Country	Name	City	State
China	Zigong First People's Hospital	Zigong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Zigong No.1 Peoples Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep medullary veins score	In this study, deep medullary veins (DMVs) were counted by SWI sequence.	2022.01-2025.1