MyelinopathyWMLNCT06608251
Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury
An observational study of Myelinopathy, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelinopathy
- What is being tested?
- white matter lesion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: older than 45 years old and without stoke be able to cooperate with the improvement of brain MRI examination
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myelinopathy
- Being tested
- white matter lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024.06.01-2027.06.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelinopathyStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Zhang, Doctor, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608251
- Sponsor's protocol ID
- KY20240123-07
- Acronym
- WML
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury
- ClinicalTrials.gov ID
- NCT06608251
- Acronym / sponsor ID
- WML / KY20240123-07
- Conditions
- Myelinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- older than 45 years old and without stoke be able to cooperate with the improvement of brain MRI examination
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white matter lesionAccording to the results of magnetic resonance, they were divided into white matter degeneration group and non-white matter degeneration group | Diagnostic test | – |
Primary outcome
myelinopathy
Time frame: 2024.06.01-2027.06.01
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Zhang, Doctor principal investigator
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelinopathy, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myelinopathy (time frame: 2024.06.01-2027.06.01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.