Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06890702
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collect samples of urine, fecal, cerebrospinal fluid, blood, plaques, emboli, drainage fluid, bone marrow, lymph nodes, pia mater, dura mater and brain tissue etc.al from patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2038-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '10 years', 'description': 'Death during the follow-up in every single reason'}, {'measure': 'Stroke of any kind', 'timeFrame': '10 years', 'description': 'Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage'}], 'secondaryOutcomes': [{'measure': 'Rehospitalization', 'timeFrame': '10 years', 'description': 'The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation'}, {'measure': 'National Institute of Health stroke scale (NIHSS score)', 'timeFrame': '10 years', 'description': 'The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome.'}, {'measure': 'modified Ranking score (mRS)', 'timeFrame': '10 years', 'description': 'The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Ischemic Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this single-center prospective observational study is to identify and evaluate new biomarkers for ischemic cerebrovascular disease (ICVD) to aid in early diagnosis, individualized treatment planning, and prognosis prediction in affected patients. The main questions it aims to answer are:\n\nCan specific biomarkers help in identifying high-risk individuals before disease onset? Can these biomarkers predict disease progression and treatment response? Researchers will compare patients diagnosed with ICVD and healthy controls from a medical check-up center to assess differences in biomarker expression and their clinical significance.\n\nParticipants will:\n\nProvide blood, cerebrospinal fluid, urine, and stool samples for biomarker analysis.\n\nUndergo clinical imaging (CT, MRI, PET-CT) and functional assessments. Be followed up at 3, 6, 12, 24, 36, and 48 months for clinical outcomes and biomarker changes.\n\nThis study aims to develop a comprehensive biomarker-based prediction model to enhance the diagnosis and management of ischemic cerebrovascular disease.', 'detailedDescription': 'The detaited information about this trial is described below\n\n1. Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.\n2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.\n3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic cerebrovascular disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from Janurary 1, 2025 - December 31, 2035', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic cerebrovascular disease has been proved by clinical symptoms and imaging examinations,including transient ischemic attack, cerebral ischemic stroke, steal syndrome, chronic cerebral hypoperfusion, ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)\n* With severe systemic disease, are expected to survive \\< 3 months\n* Patients will not able to provide continuous follow-up information'}, 'identificationModule': {'nctId': 'NCT06890702', 'briefTitle': 'Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease', 'orgStudyIdInfo': {'id': 'TJ-IRB202509068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ischemic cerebrovascular disease', 'description': 'clinical diagnosis with ischemic cerebrovascular disease', 'interventionNames': ['Diagnostic Test: biomaker levels']}, {'label': 'health control', 'description': 'age- and sex-matched control individuals', 'interventionNames': ['Diagnostic Test: biomaker levels']}], 'interventions': [{'name': 'biomaker levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'this study will discover and validate novel biomarkers (including urine, feces, cerebrospinal fluid, blood, plaques, emboli, drainage fluid, bone marrow, lymph nodes and brain tissue etc al) of ischemic cerebrovascular disease', 'armGroupLabels': ['health control', 'ischemic cerebrovascular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daishi Tian', 'role': 'CONTACT', 'email': 'tiands@tjh.tjmu.edu.cn', 'phone': '86-27-83663337'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daishi Tian', 'role': 'CONTACT', 'email': 'tiands@tjh.tjmu.edu.cn', 'phone': '86-27-83663337'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Luo-Qi Zhou', 'role': 'CONTACT', 'email': 'zhouluoqi@tjh.tjmu.edu.cn', 'phone': '86-27-83663337'}, {'name': 'Xiaowei Pang', 'role': 'CONTACT', 'email': 'pangxiaowei1998@163.com', 'phone': '86-27-83663337'}], 'overallOfficials': [{'name': 'Dai-Shi Tian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Daishi Tian', 'investigatorAffiliation': 'Tongji Hospital'}}}}