Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-12 @ 9:36 AM
Study NCT ID:
NCT03919305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-04-18
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Venous Thrombosis Cohort Study in China Mainland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-16', 'size': 61140, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-16T11:28', 'hasProtocol': False}, {'date': '2019-04-16', 'size': 47379, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-04-16T11:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA detection will be conducted in a ramdom selection of 300 blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death rate', 'timeFrame': '1 year from baseline', 'description': 'A combination of death form of all causes'}, {'measure': 'Functional independence', 'timeFrame': '1 year from baseline', 'description': 'Defined as modified Rankin score (0-5) equal to or lower than 2'}, {'measure': 'Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis', 'timeFrame': '1 year from baseline', 'description': 'Diagnosed by DSA, MRV, CTV or HR-MRI'}, {'measure': 'Incidence of hemorrhagic complication', 'timeFrame': '1 year from baseline', 'description': 'Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage'}, {'measure': 'Incidence of sinus wall rupture', 'timeFrame': '1 year from baseline'}, {'measure': 'Incidence of acute ischemic stroke', 'timeFrame': '1 year from baseline'}, {'measure': 'Incidence of acute myocardial infarction', 'timeFrame': '1 year from baseline'}, {'measure': 'Incidence of pulmonary embolism', 'timeFrame': '1 year from baseline'}, {'measure': 'Incidence of deep venous thrombosis', 'timeFrame': '1 year from baseline'}], 'secondaryOutcomes': [{'measure': 'Incidence of epilepsy', 'timeFrame': '1 year from baseline'}, {'measure': 'Incidence of allergic reaction', 'timeFrame': '1 year from baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral venous sinus thrombosis', 'Deep cerebral vein thrombosis', 'Cortical vein thrombosis', 'Cohort study', 'Real world evidence', 'Observational study', 'China mainland', 'Cerebral venous system thrombosis'], 'conditions': ['Cerebral Venous Sinus Thrombosis', 'Deep Cerebral Vein Thrombosis', 'Cortical Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'This study was aimed to reveal the clinical features,natural history of the diseases and current therapeutic situations of cerebral venous thrombosis (CVT) in China mainland. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT.', 'detailedDescription': 'cerebral venous thrombosis (CVT) is caused by a clot in the cerebral vein, which resulted in an obstruction of the blood outflow. CVT mainly includes cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis. However, the epidemiological features of CVT in China mainland remained obscure. This study was aimed to establish a multicenter cohort recruiting patients with CVT across 31 provinces and municipalities in China mainland. Clinical features,natural history of the diseases and current therapeutic situations will be analyzed to reveal the epidemiological features of CVT. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT. Patients will be followed-up at 1, 3, 6, 12 months from baseline to evaluate the clinical prognosis and therapeutic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (DSA), magnetic resonance venography (MRV), computed tomography venography (CTV) or high-resolution magnetic resonance imaging (HR-MRI).\n\nExclusion Criteria:\n\n• None of the patient, trustee or immediate family members signed the informed consent.'}, 'identificationModule': {'nctId': 'NCT03919305', 'acronym': 'CCC', 'briefTitle': 'Cerebral Venous Thrombosis Cohort Study in China Mainland', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Cerebral Venous Thrombosis Cohort Study in China Mainland', 'orgStudyIdInfo': {'id': 'CVT-China'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Min Li, MD, PhD', 'role': 'CONTACT', 'email': '812879698@qq.com', 'phone': '+86-18701519698'}], 'overallOfficials': [{'name': 'Xunming Ji, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}