Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-28 @ 10:36 PM
Study NCT ID:
NCT05714735
Status:
UNKNOWN
Last Update Posted:
2023-02-06
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001929', 'term': 'Brain Edema'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'One year', 'description': 'Death'}, {'measure': 'Bleeding events', 'timeFrame': 'One year', 'description': 'Intracerebral Hemorrhage'}], 'secondaryOutcomes': [{'measure': 'Brain swelling', 'timeFrame': 'One year', 'description': 'Brain swelling score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Swelling,Subarachnoid Hemorrhage,Artery Aneurysmal'], 'conditions': ['Arterial Aneurysm']}, 'descriptionModule': {'briefSummary': 'Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations', 'detailedDescription': 'Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with anterior circulation aneurysmal subarachnoid hemorrhage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age 18-70 years;\n* Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.\n\nExclusion criteria:\n\n* Hunt-Hess grade I-III on admission;\n* patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;\n* poor general condition or combined with pregnancy , malignant tumors, etc.'}, 'identificationModule': {'nctId': 'NCT05714735', 'acronym': 'SMCV', 'briefTitle': 'SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal', 'orgStudyIdInfo': {'id': 'BAOAN SMCV in SAH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Whole-brain venography', 'description': 'Cerevbral venography', 'interventionNames': ['Radiation: Cerebral Venography']}], 'interventions': [{'name': 'Cerebral Venography', 'type': 'RADIATION', 'description': 'Cerebral Venography Observation by DSA examinations', 'armGroupLabels': ['Whole-brain venography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'The People Hospital of Shenzhen Baoan', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'qiaoyu huang, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The People Hospital of Shenzhen Baoan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'The People Hospital of Baoan Shenzhen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}