Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06741332
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the time from patient arrival to the transfer decision to a thrombectomy-capable center', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The primary goal is to assess how much the Methinks Stroke Suite reduces the time from patient arrival at the Local-SC to the transfer decision (time-to-transfer decision) to a thrombectomy-capable center.'}], 'secondaryOutcomes': [{'measure': 'Performance evaluation of the NCCT-LVO algorithm for detecting large vessel occlusions (LVO)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assessment of Methinks Stroke SuiteI stroke accuracy at predicting the presence of vessel occlusions.'}, {'measure': 'Global reduction of workflow times', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Reduction of Door-in to Door-out at the Local-SC, arrival at the Local-SC to groin puncture for patients receiving EVT'}, {'measure': 'Improvement in treatment rates', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Populational EVT thrombectomy rates'}, {'measure': 'Functional outcome at 90 days', 'timeFrame': '3 months', 'description': 'mRS at 90 days'}, {'measure': 'User experience evaluation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'User experience evaluation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Ischemic Stroke', 'Acute stroke', 'mDIDO', 'Artificial Intelligence'], 'conditions': ['Stroke', 'Stroke Acute', 'Ischemic Stroke, Acute', 'Thrombectomy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an AI-based imaging software, Methinks Stroke Suite, can reduce the time to transfer stroke patients who need thrombectomy from local stroke centers to specialized centers. The study focuses on acute stroke patients who are initially evaluated at local stroke centers that cannot perform endovascular therapy (EVT). The main questions it aims to answer are:\n\n* Does Methinks Stroke Suite reduce the time it takes to decide if a patient needs to be transferred for thrombectomy?\n* How accurate is the AI software in identifying patients who are candidates for EVT?\n\nResearchers will compare the AI-based workflow to a historical cohort to see if the Methinks Stroke Suite improves transfer decisions and treatment times.\n\nParticipants will:\n\n* Undergo a CT scan at the local stroke center, which will be analyzed by Methinks Stroke Suite.\n* Be transferred to a thrombectomy-capable center if the AI + clinical judgment identifies them as potential EVT candidates.\n* Be followed for 90 days after their stroke to assess recovery outcomes.', 'detailedDescription': "Study Overview:\n\nThe CATalyze-AI study aims to evaluate the impact of integrating the Methinks Stroke Suite, an artificial intelligence (AI) imaging software, into the workflow of stroke centers unable to perform endovascular therapy (EVT). This is a prospective, multicenter, quasi-experimental clinical trial focusing on acute stroke patients initially assessed at local stroke centers (Local-SC) in Catalonia, Spain. The introduction of this AI algorithm is expected to improve the decision-making process for transferring patients who may benefit from EVT, reducing time-to-transfer decisions.\n\nPrimary Objective:\n\nThe primary goal is to assess how much the Methinks Stroke Suite reduces the time from patient arrival at the Local-SC to the transfer decision (time-to-transfer decision) to a thrombectomy-capable center.\n\nSecondary Objectives:\n\nAccuracy of Methinks: Evaluate the software's accuracy in identifying large vessel occlusion (LVO) candidates requiring EVT.\n\nWorkflow Efficiency: Measure global workflow improvements, including door-in to door-out (DIDO) times and time to groin puncture.\n\nThrombectomy Rates: Assess population-wide EVT rates. Functional Outcomes: Evaluate patient recovery based on functional outcomes at 90 days post-stroke.\n\nSafety Analysis: Monitor complications during patient transfers, especially in cases where Methinks does not suspect LVO.\n\nClinician Experience: Conduct a parallel study to assess the satisfaction of clinicians using the software.\n\nStudy Design:\n\nThis is a quasi-experimental, open-label trial. The Methinks Stroke Suite will be integrated into the usual stroke care workflow of participating centers, and the results will be compared with a historical cohort. Subjects will be followed for 90 days post-stroke to evaluate outcomes.\n\nStudy Setting and Population:\n\nThe study will take place across several centers in Catalonia, Spain, including:\n\nHospital Universitari Vall d'Hebron Hospital General de Granollers Consorci Hospitalari de Vic Hospital Clínic de Barcelona Centre Hospitalari Manresa - Fundació Althaia Mútua de Terrassa The target population is acute stroke patients evaluated at Local-SC. A sample size of 250 patients is projected. All patients meeting the inclusion criteria will be enrolled, and consent for data collection will be obtained at the destination center.\n\nEligibility Criteria:\n\nInclusion Criteria:\n\nSuspected acute stroke. Patients aged 18 years or older, with no upper age limit. Stroke onset \\<24 hours since last known well. A non-contrast CT (NCCT) performed at the Local-SC and processed by the Methinks Stroke Suite.\n\nInformed consent from the patient or legally designated representative.\n\nExclusion Criteria:\n\nPatients in a coma (NIHSS \\> 1). Patients requiring life support due to unstable clinical status. Imaging that does not meet DICOM Tag and Acquisition Requirements.\n\nHistorical Cohort:\n\nFor time-reduction comparisons, a control group will be selected retrospectively from each participating center. These control patients will match study participants based on age, pre-stroke functional status, baseline NIHSS score, working hours (office vs. off-hours), and use of intravenous thrombolysis.\n\nIntervention and Workflow:\n\nWhen patients arrive at a Local-SC, they will be evaluated for suspected stroke and undergo a CT scan. Methinks Stroke Suite will analyze the imaging in real-time, and its results will be shared with the referring stroke neurologist. Based on the AI results and clinical judgment, patients suspected of LVO will be transferred to a thrombectomy-capable center.\n\nIn cases where Methinks does not detect LVO, CTA (CT Angiography) may be performed to reassess the patient\\'s status. Transfer decisions will be based on clinical judgment and the results of this additional imaging.\n\nPrimary Outcome:\n\nThe primary outcome is the reduction in time-to-transfer decision, defined as the time from patient arrival at the Local-SC to the notification to Emergency Medical Services (EMS) for patient transfer to a thrombectomy-capable center.\n\nSecondary Outcomes:\n\nAccuracy of Methinks Stroke Suite in detecting LVOs. Improvement in workflow times, including the time from Local-SC arrival to groin puncture.\n\nIncreased EVT rates among patients flagged by Methinks as LVO positive. Safety outcomes, including complications during transfer. Functional outcomes based on the modified Rankin Scale (mRS) at 90 days. Clinician satisfaction with the use of Methinks Stroke Suite.\n\nSample Size and Power Calculation:\n\nThe study aims to include 152 patients to detect a 10-minute reduction in transfer decision time, with 80% power and a significance level of 0.05. To account for potential enrollment failures, the target is set at 250 patients.\n\nBlinding and Statistical Analysis:\n\nThe trial is not blinded, as the intervention is visible to clinicians. However, neuroimaging and clinical data will be assessed by blinded reviewers to ensure unbiased evaluation. Statistical analysis will compare time-to-transfer decision between groups and measure accuracy (sensitivity, specificity) of Methinks predictions. Quantitative variables will be described using means and standard deviations, while qualitative variables will be analyzed using chi-square or Fisher's exact tests.\n\nData Management:\n\nData will be collected through existing stroke registries (CICAT, SITREM, TICAT, and SONIIA). Methinks Stroke Suite will automatically log patient imaging data. Blinded investigators will review the data to ensure it complies with the protocol.\n\nEthics and Regulatory Compliance:\n\nThe study follows European regulations on data protection and ethical standards. Informed consent will be obtained from all participants, and the Fundació Vall d'Hebron Institut de Recerca (VHIR) acts as the study sponsor.\n\nTimeline:\n\nThe patient inclusion period is expected to last 18 months, followed by 3 months of follow-up, and 2 months for data analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with an acute stroke evaluated in a local stroke center. Sample size is projected to be 250 patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected acute stroke patients\n2. \\>18 years with no upper age limit\n3. Included \\&lt; 24 h since last seen well\n4. Non-contrast CT is available at the local stroke center\n5. Image has been processed by Methinks Stroke Suite\n6. Informed consent obtained from a patient or his or her legally designated representative (if locally required).\n\nExclusion Criteria:\n\n1. Patients in a coma (NIHSS item of consciousness \\&gt;1)\n2. Patients with unstable clinical status who require emergent life support care\n3. Subject imaging does not meet Image Acquisition and DICOM Tag Requirements'}, 'identificationModule': {'nctId': 'NCT06741332', 'acronym': 'CATalyze-AI', 'briefTitle': 'Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software', 'orgStudyIdInfo': {'id': 'PR(AG)644-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Historical cohort', 'description': 'Control group selected retrospectively from each participating center', 'interventionNames': ['Other: Normal CT scans evaluation']}, {'label': 'Prospective cohort', 'description': 'Patients included prospectively after the integration of the Methinks Stroke Suit into the usual stroke care workflow of the participating centers', 'interventionNames': ['Device: Methinks software']}], 'interventions': [{'name': 'Methinks software', 'type': 'DEVICE', 'description': 'Introduction in the stroke code workflow the Methinks AI software capable of detecting LVO on NCCT and CTA, and ICH on NCCT.', 'armGroupLabels': ['Prospective cohort']}, {'name': 'Normal CT scans evaluation', 'type': 'OTHER', 'description': 'The control group is obtained from a historical cohort at each participating center. We include consecutive suspected acute stroke patients who meet the same inclusion/exclusion criteria defined above, except for Methinks image processing.', 'armGroupLabels': ['Historical cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08402', 'city': 'Granollers', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Dolores Cocho, DOCTOR', 'role': 'CONTACT', 'email': 'dcocho@fphag.org', 'phone': '938 42 50 00'}], 'facility': 'Hospital General de Manresa Granollers', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Olivé', 'role': 'CONTACT', 'email': 'marta.olive@vallhebron.cat', 'phone': '934893000', 'phoneExt': '6326'}], 'facility': 'Hospital Vall Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Marta Olivé', 'role': 'CONTACT', 'email': 'marta.olive@vallhebron.cat', 'phone': '34 93 489 30 00', 'phoneExt': '6326'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Methinks Software SL', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}