Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT05299034
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2022-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081364', 'term': 'Multiparametric Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mRS at 90 days', 'timeFrame': '90 days after stroke', 'description': 'Percentage of patients with functional independence, defined as mRS \\< or =2 on day 90 as assessed centrally by blinded evaluators of the Catalan Stroke Master Plan.'}, {'measure': 'Rate of patients treated with mechanical thrombectomy', 'timeFrame': 'less than 24 hours after the diagnostic test'}], 'secondaryOutcomes': [{'measure': 'Mortality at discharge and at day 90', 'timeFrame': '90 days after stroke'}, {'measure': 'Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points', 'timeFrame': 'From 24 to 72 hours after stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:\n\n1. To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.\n2. To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.\n3. To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in \\>6h from the onset of symptoms.\n\nMETHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases\n\n1. retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.\n2. validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.\n\nResponse variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry', 'healthyVolunteers': False, 'eligibilityCriteria': '* SUBSTUDY 1. OPTIMIZATION OF IMAGING SELECTION METHODS FOR SELECTING STROKE PATIENTS FOR REPERFUSION TREATMENT IN THE EXTENDED WINDOW.\n\n \\- Inclusion criteria: Consecutive patients registered in the CICAT registry between the years 2019 and 2021 with a stroke who meet the following criteria\n 1. Age older than 18 years,\n 2. Diagnosis of acute cerebral infarction,\n 3. More than six hours of evolution or uncertain chronology of symptoms,\n 4. Absence of disability prior to stroke (modified Rankin score 0-2),\n 5. NIHSS score\\>5,\n 6. Neuroimaging study including at least one non-contrast cranial CT scan within 60 minutes of arrival at the hospital center.\n* SUBSTUDY 2. OPTIMIZATION OF CIRCUITS AND TRANSFER MODEL IN PATIENTS WITH STROKE IN THE EXTENDED WINDOW OF TREATMENT.\n\n * Inclusion criteria: Selection of consecutive, prospective patients to be included in the CICAT registry between January 2023 and March 2024 with stroke meeting the following criteria:\n\n 1. Age over 18 years,\n 2. Suspicion of acute cerebral infarction,\n 3. More than six hours of evolution or uncertain chronology of symptoms,\n 4. absence of pre-stroke disability (modified Rankin score 0-2),\n 5. NIHSS score greater than 5.'}, 'identificationModule': {'nctId': 'NCT05299034', 'acronym': 'VESTA', 'briefTitle': 'Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)', 'orgStudyIdInfo': {'id': 'PI21/01548'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients 6-24h receiving non-contrast CT + CTA', 'description': 'Stroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy', 'interventionNames': ['Diagnostic Test: Non contrast CT+CT angiography']}, {'label': 'Stroke patients 6-24h receiving multimodal imaging', 'description': 'Stroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy', 'interventionNames': ['Diagnostic Test: Multiparametric imaging']}], 'interventions': [{'name': 'Multiparametric imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'MR perfusion or multiparametric CT including NCCT, CTA and CTP', 'armGroupLabels': ['Stroke patients 6-24h receiving multimodal imaging']}, {'name': 'Non contrast CT+CT angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'NCCT+CTA', 'armGroupLabels': ['Stroke patients 6-24h receiving non-contrast CT + CTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Germans Trias i Pujol Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'María Hernández Pérez', 'investigatorAffiliation': 'Germans Trias i Pujol Hospital'}}}}