NCT06608251

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 23, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

August 7, 2024

Last Update Submit

September 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

white matter lesionDIAGNOSTIC_TEST

According to the results of magnetic resonance, they were divided into white matter degeneration group and non-white matter degeneration group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.;
  • accompanied by neurological deficit symptoms;
  • refusal to participate in the study;
  • Other conditions judged by the investigator to be unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

Study Officials

  • Ying Zhang, Doctor

    Nanjing First Hospital, Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2024

First Posted

September 23, 2024

Study Start

June 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

September 23, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations