Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05906420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2023-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Posterior Circulation ASTRAL Prognostic Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020520', 'term': 'Brain Infarction'}], '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': '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': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 months modified Ranking scale', 'timeFrame': 'January 2003-December 2021', 'description': 'evaluation of 3 months neurological disability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke Ischemic', 'Stroke Acute', 'Posterior Circulation Brain Infarction', 'Risk Score']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event.\n\nParticipants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event \\<3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants included in this study are exclusively patients with acute ischemic stroke of the posterior circulation arriving at the hospital within 24h since last proof of good health. These patients must have a modified Rankin Score \\<3 prior the event and available data concerning: age, NIHSS, glucose levels at admission, mRS prior to event and 3 months after the event and acute phase imaging characteristics (CT and/or MRI) including large vessel occlusion, leukoaraiosis and ASPECTS score from the acute CT scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated posterior circulation strokes based on clinical or/and imaging evidence.\n* Arriving within 24h at hospital since last proof of good health.\n\nExclusion Criteria:\n\n* no available data for 3 months modified Rankin Score\n* modified Rankin Scoreā„3 prior the event'}, 'identificationModule': {'nctId': 'NCT05906420', 'briefTitle': 'Posterior Circulation ASTRAL Prognostic Score', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Pc-ASTRAL Score for the Prediction of 3 Months Functional Outcome in Acute Ischemic Stroke at the Posterior Circulation', 'orgStudyIdInfo': {'id': 'pc-ASTRAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASTRAL', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Basel cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Berlin cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Bern Cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Bologna cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Dijon cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Lisbon cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Israel cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Innsbruck cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'St. Gallen cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Lugano cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Chicago cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'West Virginia cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Zurich cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}, {'label': 'Seoul cohort', 'interventionNames': ['Diagnostic Test: ASTRAL prognostic score']}], 'interventions': [{'name': 'ASTRAL prognostic score', 'type': 'DIAGNOSTIC_TEST', 'description': 'ASTRAL prognostic score', 'armGroupLabels': ['ASTRAL', 'Basel cohort', 'Berlin cohort', 'Bern Cohort', 'Bologna cohort', 'Chicago cohort', 'Dijon cohort', 'Innsbruck cohort', 'Israel cohort', 'Lisbon cohort', 'Lugano cohort', 'Seoul cohort', 'St. Gallen cohort', 'West Virginia cohort', 'Zurich cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'state': 'Central Macedonia', 'country': 'Greece', 'facility': 'First Propedeutic Department of Internal Medicine & Stroke Unit, AHEPA University Hospital, Aristotle University of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '1011', 'city': 'Lausanne', 'state': 'Vaud Canton', 'country': 'Switzerland', 'facility': 'Stroke Center, Department of clinical neurosciences, Lausanne University Hospital and University of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine George Ntaios', 'investigatorFullName': 'George Ntaios', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}