Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-26 @ 6:55 PM
Study NCT ID:
NCT04951518
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VAN Assessment Tool in the Treatment of Acute Ischemic Stroke
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of VAN Assessment Tool', 'timeFrame': '1 Year', 'description': 'To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction'}], 'secondaryOutcomes': [{'measure': 'Eligibility for Thrombolysis', 'timeFrame': '1 Year', 'description': 'To investigate effect of the VAN tool to predict persons eligible for thrombolysis'}, {'measure': 'Eligibility for Thrombectomy', 'timeFrame': '1 Year', 'description': 'To investigate effect of the VAN tool to predict persons eligible for thrombectomy'}, {'measure': 'Door to Intervention Time', 'timeFrame': '1 Year', 'description': 'To investigate the effect of prehospital notification of VAN positive status vs routine notification on time door to needle or door to thrombectomy time'}, {'measure': 'Modified Rankin Score', 'timeFrame': '1 Year', 'description': 'To compare the discharge disposition and Rankin score of patients post intervention with VAN prenotification vs routine notification. Rankin scores ranging from 0 - 5, with 0 being fully functioning and independent, and 5 being severe disability requiring constant nursing care.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction', 'detailedDescription': 'The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.\n\nThe investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anyone experiencing acute ischemic stroke symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac\n\nExclusion Criteria:\n\n* Stroke patients who arrive directly to the hospital (without the use of EMS services)'}, 'identificationModule': {'nctId': 'NCT04951518', 'briefTitle': 'VAN Assessment Tool in the Treatment of Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Washington Regional Medical Center'}, 'officialTitle': 'VAN - Training of Emergency Medical Services to Improve Stroke Outcomes in Northwest Arkansas', 'orgStudyIdInfo': {'id': 'V-109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Van Positive', 'description': 'Large Vessel Occlusion Positive', 'interventionNames': ['Other: VAN Stroke Scale']}, {'label': 'Van Negative', 'description': 'Large Vessel Occlusion Negative', 'interventionNames': ['Other: VAN Stroke Scale']}], 'interventions': [{'name': 'VAN Stroke Scale', 'type': 'OTHER', 'description': 'V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients', 'armGroupLabels': ['Van Negative', 'Van Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Washington Regional Medical Center', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}