Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 7:26 AM
Study NCT ID:
NCT03370094
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-Stroke: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine - Feasibility
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of the patient evaluation by remote Audio/video session', 'timeFrame': '1 hour', 'description': "The proportion of successfully realized 'telestroke' interviews (=patient has a stroke yes/no) in comparison to final diagnosis by the caring stroke team."}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of an automated biometric software', 'timeFrame': '12 months', 'description': 'The proportion of correct stroke diagnosis by the automatic biometric assessment compared to the final diagnosis of the caring stroke team.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'Observational Study to investigate the technical feasibility, implementation into current diagnostic and treatment pathways and the diagnostic accuracy of the remote patient assessment by using mobile telecommunication ahead of hospitalization.', 'detailedDescription': 'On-site, pre-hospital clinical assessment of patients with suspected acute stroke can accelerate further diagnostic and treatment pathways after patient arrival at the emergency room or the dedicated stroke center. Interactive video and audio streaming connecting on-site paramedics to a stroke center based stroke physicians can help to overcome these hurdles. Patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire may enable a pre-hospital decision on the need of expedited diagnostic and treatment procedures after arrival at the dedicated stroke center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The current phase of the project ("Feasibility") will include patients with suspected acute stroke already admitted to the ER of the University Hospital Basel, and patients with suspected acute stroke and who are referred to the Stroke Center of USB by the paramedics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient older or equal than 18 years with suspected acute stroke as per the first judgement of the paramedics on-site.\n* written informed consent by the patient, or legal representative (next-of kin) or informed consent by an independent physician not involved in the study\n\nExclusion Criteria:\n\n-patients with symptoms not attributable to stroke in the emergency onsite ( observation of epileptic seizure, recent cerebral trauma, prior syncope or comatose state)'}, 'identificationModule': {'nctId': 'NCT03370094', 'acronym': 'Tele-Stroke', 'briefTitle': 'Tele-Stroke: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine - Feasibility', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine', 'orgStudyIdInfo': {'id': 'PP-16-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with suspected stroke', 'description': "patients with suspected stroke due to paramedic's initial evaluation of face, arm, and speech function will be diagnosed with audio-video-streaming of suspected stroke symptoms and signs", 'interventionNames': ['Diagnostic Test: Audio-video-streaming of suspected stroke symptoms and signs']}], 'interventions': [{'name': 'Audio-video-streaming of suspected stroke symptoms and signs', 'type': 'DIAGNOSTIC_TEST', 'description': 'The diagnosis based on the patient evaluation by end-to-end encrypted real-time video will be compared to the gold standard, consisting of an in-person neurological examination by a stroke specialist in patients with suspected acute stroke.', 'armGroupLabels': ['patients with suspected stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Philippe Lyrer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'propatient Basel', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}