Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04578002
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2020-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine
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': 'ESTIMATED', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Door-to-treatment-time (minutes)', 'timeFrame': 'one point assessment at baseline', 'description': 'Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.'}], 'secondaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale (NIHSS) at 24hours', 'timeFrame': 'one point assessment at 24hours after hospital admission', 'description': "Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) at 90 days', 'timeFrame': 'one point assessment at 90 days after hospital admission', 'description': "Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."}, {'measure': 'modified Rankin Scale (mRS) at 90 days', 'timeFrame': 'one point assessment at 90 days after hospital admission', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-hospital triage', 'Stroke, suspected', 'Telemedicine', 'telemedical triage', 'Door-to-treatment-time'], 'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.', 'detailedDescription': "One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected acute stroke as per the first judgement of the paramedics on-site\n\nExclusion Criteria:\n\n* Patients with a known history of epilepsia or non-epileptic seizures\n* Patients after/while displaying an epileptic seizure\n* Recent head trauma\n* Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination'}, 'identificationModule': {'nctId': 'NCT04578002', 'acronym': 'Telestroke 2', 'briefTitle': 'Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study', 'orgStudyIdInfo': {'id': '2022-0126; me20Lyrer'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prehospital telemedical triage', 'type': 'OTHER', 'description': 'Prehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT. All other patients will follow conventional stroke path.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Philippe Lyrer, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'philippe.lyrer@usb.ch', 'phone': '+41 (0) 61 265 4435'}, {'name': 'Sebastian Thilemann, Dr. med.', 'role': 'CONTACT', 'email': 'sebastian.thilemann@usb.ch', 'phone': '+41 61 32 85307'}, {'name': 'Philippe Lyrer, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sebastian Thilemann, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stroke Center, Neurology, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Philippe Lyrer, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'philippe.lyrer@usb.ch', 'phone': '+41 61 265 4435'}, {'name': 'Sebastian Thilemann, Dr. med.', 'role': 'CONTACT', 'email': 'sebastian.thilemann@usb.ch'}], 'overallOfficials': [{'name': 'Philippe Lyrer, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stroke Center, Neurology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'propatient Forschungsstiftung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}