Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT03359434
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'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'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of intracranial hemorrhagic complications', 'timeFrame': '36 hours after baseline', 'description': 'number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Stroke', 'Blood Pressure', 'Cerebral Hemorrhage'], 'conditions': ['Acute Stroke', 'Blood Pressure', 'Cerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'A monocentric, non-randomized, prospective study in which each patient is his/her own control.\n\nThe study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.', 'detailedDescription': 'Patients will be followed for 72 hours:\n\n* inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.\n* within 24 hours after reperfusion: blood pressure measurements\n* at 24 hours: NIHSS score.\n* Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes).\n* 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1).\n* Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score).\n\nExclusion Criteria:\n\n* Per-procedure hemorrhagic complications (prior to reperfusion)\n* Known pregnancy'}, 'identificationModule': {'nctId': 'NCT03359434', 'acronym': 'BP-METROLOGY', 'briefTitle': 'Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke', 'orgStudyIdInfo': {'id': 'MMI_2017_12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two measuring methods of blood pressure', 'interventionNames': ['Device: Clearsight device (Edwards) around the finger', 'Device: Intermittent blood pressure measurements with cuff.']}], 'interventions': [{'name': 'Clearsight device (Edwards) around the finger', 'type': 'DEVICE', 'description': 'Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:', 'armGroupLabels': ['Two measuring methods of blood pressure']}, {'name': 'Intermittent blood pressure measurements with cuff.', 'type': 'DEVICE', 'description': 'Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion', 'armGroupLabels': ['Two measuring methods of blood pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique A de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'MAZIGHI Mikael, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ophtalmologique A. de Rothschild'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}