Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury (WML)

The cases were screened according to the inclusion criteria, and after the patients signed the informed consent, the clinical data were collected, the imaging data were evaluated, and blood samples were taken for follow-up measurements. In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelinopathy
• Intervention / Treatment: Diagnostic test: white matter lesion

Detailed Description

In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.Inluding CRP，Complete blood count，Liver and kidney function indicators，et.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

older than 45 years old and without stoke be able to cooperate with the improvement of brain MRI examination

Description

Inclusion Criteria：

1. Be older than 45 years old;
2. Patients admitted to the Department of Neurology due to headache, vertigo, anxiety, etc.;
3. There were no symptoms of neurological deficit on physical examination;
4. Able to cooperate with the improvement of brain MRI examination;
5. Sign the informed consent form.

Exclusion Criteria:

1. History of stroke, traumatic brain injury, intracranial tumor, central nervous system infection, active malignant tumor, thyroid disease, autoimmune disease, active or chronic inflammatory disease, severe liver and kidney impairment, etc.;
2. accompanied by neurological deficit symptoms;
3. refusal to participate in the study;
4. Other conditions judged by the investigator to be unsuitable for enrollment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myelinopathy	The degree of damage to the white matter of the brain is judged based on the magnetic resonance Fazekas score(1-3), with the higher scores indicating the damage more severe.	2024.06.01-2027.06.01

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Ying Zhang, Doctor, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KY20240123-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No