Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 12:34 AM
Study NCT ID:
NCT04373993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehospital Minutes Count During a Stroke.
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time delay from ictus to hospital arrival', 'timeFrame': 'Within 4 hours', 'description': 'Delay from first symptoms of stroke until arrival at hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. The research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. The project will gather data from various parts of Norway and from a University hospital in Switzerland for comparison between regions and countries. Data will be retrieved through intrahospital and prehospital medical records from various parts of Norway (Nordland Hospital, Akershus University Hospital and Helgeland Hospital) and from Basel University hospital in Switzerland. Knowledge of factors associated with delays will be compared for regions in the north and south of Norway, as well as abroad. The information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients discharged from the respective hospitals with a diagnosis of stroke during the period of inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Final diagnosis of stroke at discharge from hospital\n\nExclusion Criteria:\n\n• Hospital admission later than one week from stroke onset'}, 'identificationModule': {'nctId': 'NCT04373993', 'briefTitle': 'Prehospital Minutes Count During a Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'Nordlandssykehuset HF'}, 'officialTitle': 'Prehospital Minutes Count During a Stroke. Factors Associated With Prehospital Delays With Data From Various Regions in Norway and One Region in Switzerland', 'orgStudyIdInfo': {'id': '2016/1729 REK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nordlandssykehuset HF'}, {'label': 'Akershus universitetsssykehus'}, {'label': 'Helgelandssykehuset'}, {'label': 'Basel University Hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8092', 'city': 'Bodø', 'country': 'Norway', 'facility': 'Maria Carlsson', 'geoPoint': {'lat': 67.28267, 'lon': 14.37513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordlandssykehuset HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Akershus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}