Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-05 @ 11:57 AM
Study NCT ID:
NCT06530693
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from stroke onset to endovascular therapy', 'timeFrame': 'From time of stroke onset to endovascular therapy, assessed on day 0 of admission', 'description': 'This outcome will assess process measures for acute stroke patients'}], 'secondaryOutcomes': [{'measure': 'Time from stroke onset IVT', 'timeFrame': 'From time of stroke onset to IVT, Assessed on day 0 of admission', 'description': 'This outcome will assess process measures for acute stroke patients'}, {'measure': 'Rate of bypass of non-ESCs for rural and urban patients.', 'timeFrame': 'The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission', 'description': 'This outcome will assess rates of bypass to narrow the disparity between urban and rural patients.'}, {'measure': 'Rate of bypass of non-ESCs for rural and urban patients.', 'timeFrame': 'Modified Rankin Scale of 0-2 at 90 days in patients for all stroke patients.', 'description': 'This outcome will assess good functional outcomes after stroke.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS', 'timeFrame': 'Modified Rankin Scale of 0-2 at 90 days in patients with large vessel occlusion stroke.', 'description': 'This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS', 'timeFrame': 'Modified Rankin Scale of 0-2 at 90 days for patients with intracranial hemorrhage', 'description': 'This outcome will assess good functional outcomes in patients with ICH.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS', 'timeFrame': 'Modified Rankin Scale of 0-2 at 90 days for patients with non-LVO AIS', 'description': 'This outcome will assess good functional outcomes in patients with non-LVO AIS'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.', 'timeFrame': 'Modified Rankin Scale of 0-1 at 90 days for all patients.', 'description': 'This outcome will assess excellent functional outcome after stroke.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS', 'timeFrame': 'Modified Rankin Scale of 0-1 at 90 days in patients with LVOS.', 'description': 'This outcome will assess excellent functional outcomes after stroke in patients with LVOS'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH.', 'timeFrame': 'Modified Rankin Scale of 0-1 at 90 days for patients with intracranial hemorrhage.', 'description': 'This outcome will assess excellent functional outcomes after ICH.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS.', 'timeFrame': 'Modified Rankin Scale of 0-1 at 90 days for patients with non-LVO AIS', 'description': 'This outcome will assess excellent functional outcomes after non-LVO AIS.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes', 'timeFrame': 'up to 90 days', 'description': 'This will assess good functional outcomes after stroke.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess good functional outcomes in patients with ICH.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess good functional outcomes in patients with non-LVO AIS'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess excellent functional outcome after stroke.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS.', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess excellent functional outcomes after stroke in patients with LVOS.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess excellent functional outcomes after ICH.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess excellent functional outcomes after non-LVO AIS.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on patients with hyperacute strokes To evaluate the effect of a novel prehospital stroke transport algorithm on patients with hyperacute strokes', 'timeFrame': 'Modified Rankin Scale of 0-2 at 90 days in patients with last known well to hospital arrival of <4 hour', 'description': 'This outcome will assess good functional outcomes after hyperacute ischemic stroke.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality', 'timeFrame': 'All-cause mortality at 90 days', 'description': 'This outcome will assess all-cause mortality at 90 days.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in LVOS patients', 'timeFrame': 'All-cause mortality at 90 days for LVOS patients', 'description': 'This outcome will assess all-cause mortality at 90 days for LVOS patients.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in patients with ICH', 'timeFrame': 'All-cause mortality at 90 days for patients with ICH', 'description': 'This outcome will assess all-cause mortality at 90 days for patients with ICH.'}, {'measure': 'To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality for patients with non-LVO AIS', 'timeFrame': 'All-cause mortality at 90 days for patients with non-LVO AIS', 'description': 'This outcome will assess all-cause mortality at 90 days for patients with non-LVO AIS.'}, {'measure': 'To evaluate process measures in stroke care', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to IVT'}, {'measure': 'To evaluate process measures in stroke care', 'timeFrame': 'up to 90 days', 'description': 'This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to EVT'}, {'measure': 'To evaluate process measures in stroke care', 'timeFrame': 'up to 90 days', 'description': 'Rate of IVT'}, {'measure': 'To evaluate process measures in stroke care', 'timeFrame': 'up to 90 days', 'description': 'Rate of EVT'}, {'measure': 'To compare the above processes and outcomes in rural versus urban patients', 'timeFrame': 'up to 90 days', 'description': 'mRS in rural vs urban patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This interventional trial will compare a novel prehospital stroke transport algorithm (OPUS-i) to a traditional prehospital stroke transport algorithm to improve outcomes in rural stroke patients by determining the effect of implementing a data-driven prehospital stroke algorithm on time to and endovascular therapy. The study consists of a multicenter cohort and will last 24 months but individual subject study duration is 90 days.', 'detailedDescription': 'Stroke is the fifth leading cause of death in the United States (U.S.) and causes one in six deaths from cardiovascular disease. Intravenous thrombolysis (IVT), unless contraindicated, is the standard of care for acute ischemic strokes (AIS) presenting within 4.5 hours of last known well. IVT plus endovascular therapy (EVT) is standard of care for the typically debilitating large vessel occlusion strokes (LVOS), which represent 30% of AIS. However, only a limited number of stroke centers provide EVT. Currently only 12% of all stroke patients are treated with IVT and only 8% of patients are treated with EVT. Therefore, optimizing prehospital systems of care to provide timely IVT and EVT to all patients.\n\nMost stroke patients arrive at the hospital by Emergency Medical Services (EMS). EMS clinicians use various stroke assessment tools to triage patients to the appropriate level of stroke center. Unfortunately, these prehospital stroke screen tools are imprecise and can delay care for LVOS patients. The choice of transport destination may vary by geography. In an urban area, where several stroke centers of varying capability may be concentrated in a small geographical area, there is negligible impact to the healthcare system if an ambulance bypasses the closest hospital for an ESC. In a more rural area, the decision regarding hospital transport destinations has greater implications. Transporting a patient to a farther ESC will result in a longer transport time and take an ambulance out of its primary coverage for a prolonged time. However, transporting rural stroke patients to their local non-ESC may worsen their clinical outcomes by delaying the time to EVT.\n\nTherefore, we propose to implement the novel OPUS-i prehospital stroke transport algorithm to improve outcomes for stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical impression of stroke/TIA by EMS clinicians\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT06530693', 'acronym': 'OPUS-i', 'briefTitle': 'Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)', 'orgStudyIdInfo': {'id': '30716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard transport protocol', 'description': 'Standard EMS stroke transport protocol', 'interventionNames': ['Other: OPUS-i algorithm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OPUS-i Protocol', 'description': 'Experimental OPUS-i protocol', 'interventionNames': ['Other: OPUS-i algorithm']}], 'interventions': [{'name': 'OPUS-i algorithm', 'type': 'OTHER', 'description': 'A novel pre-hospital algorithm.', 'armGroupLabels': ['OPUS-i Protocol', 'Standard transport protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Derek Isenberg, MD', 'role': 'CONTACT', 'email': 'derek.isenberg@tuhs.temple.edu', 'phone': '215-707-8020'}], 'facility': '3401 N Broad street', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Derek Isenberg, MD', 'role': 'CONTACT', 'email': 'derek.isenberg@tuhs.temple.edu', 'phone': '2157077550'}], 'overallOfficials': [{'name': 'Derek Isenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lewis Katz School of Medicine at Temple University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year after study completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}