Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT07122934
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Circulation Clot Burden Score (Pc-CBS) Predicts Clinical Outcome After Acute Ischemic Stroke Related to Posterior Circulation Occlusions : An Externally Validated Radiological Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020520', 'term': 'Brain Infarction'}], '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'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1828}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified rankin scale at three months', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke', 'Posterior Circulation Brain Infarction', 'Arterial Occlusion Disease']}, 'descriptionModule': {'briefSummary': 'Posterior circulation strokes (PCS) represent \\~30% of all ischemic strokes, but existing prognostic tools are limited, especially for non-basilar artery occlusions. Accurate early outcome prediction may aid treatment decisions and clinical trial design. We developed and externally validated the Posterior Circulation Clot Burden Score (PC-CBS), a radiological tool to predict 3-month functional outcome in acute ischemic stroke due to posterior circulation occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from an acute ischemic stroke (AIS) clinically and/or radiologically attributable to a posterior circulation arterial occlusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years old\n* admitted within 24h from last known well\n* symptomatic arterial occlusion. The following arterial occlusions were eligible for inclusion: the extracranial vertebral artery between the V0 and V3 segments; the intracranial portion of the vertebral artery; the basilar artery either in its proximal, mid and/or distal segment, the P1 and/or the P2 segments of the posterior cerebral artery.\n\nExclusion Criteria:\n\n* simultaneous clinical and/or radiological strokes in the posterior and anterior circulation'}, 'identificationModule': {'nctId': 'NCT07122934', 'acronym': 'PC-CBS', 'briefTitle': 'Posterior Circulation Clot Burden Score (Pc-CBS) Predicts Clinical Outcome After Acute Ischemic Stroke Related to Posterior Circulation Occlusions : An Externally Validated Radiological Score', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Posterior Circulation Clot Burden Score (Pc-CBS) Predicts Clinical Outcome After Acute Ischemic Stroke Related to Posterior Circulation Occlusions : An Externally Validated Radiological Score', 'orgStudyIdInfo': {'id': 'PC-CBS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Development and Internal validation cohort', 'interventionNames': ['Diagnostic Test: Assessment of cervico-cerebral arterial occlusion pattern']}, {'label': 'External validation cohort', 'interventionNames': ['Diagnostic Test: Assessment of cervico-cerebral arterial occlusion pattern']}], 'interventions': [{'name': 'Assessment of cervico-cerebral arterial occlusion pattern', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of cervico-cerebral arterial occlusion pattern for the development of a radiological score', 'armGroupLabels': ['Development and Internal validation cohort', 'External validation cohort']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'Hospital de Egas Moniz', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'IRCCS Istituto delle Scienze Neurologiche di Bologna', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, {'name': 'Medical University of Graz', 'class': 'OTHER'}, {'name': 'Hôpital Rothschild', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}, {'name': 'Michigan State University', 'class': 'OTHER'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, {'name': 'EOC Lugano CH', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, {'name': 'Technische Universität Dresden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior registrar', 'investigatorFullName': 'Dr. med. Alexander Salerno, MD-PhD', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}