Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06608251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myelinopathy', 'timeFrame': '2024.06.01-2027.06.01', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelinopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'older than 45 years old and without stoke be able to cooperate with the improvement of brain MRI examination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria：\n\n1. Be older than 45 years old;\n2. Patients admitted to the Department of Neurology due to headache, vertigo, anxiety, etc.;\n3. There were no symptoms of neurological deficit on physical examination;\n4. Able to cooperate with the improvement of brain MRI examination;\n5. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. 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.;\n2. accompanied by neurological deficit symptoms;\n3. refusal to participate in the study;\n4. Other conditions judged by the investigator to be unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT06608251', 'acronym': 'WML', 'briefTitle': 'Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury', 'orgStudyIdInfo': {'id': 'KY20240123-07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'white matter lesion', 'type': 'DIAGNOSTIC_TEST', 'description': 'According to the results of magnetic resonance, they were divided into white matter degeneration group and non-white matter degeneration group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ying Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing First Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}