Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-03 @ 7:00 PM
Study NCT ID:
NCT03246256
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic 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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2017-08-03', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke', 'timeFrame': 'Within 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute', 'informed consent', 'thrombolysis'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '37021170', 'type': 'DERIVED', 'citation': 'Schuster L, Essig F, Daneshkhah N, Herm J, Hellwig S, Endres M, Dirnagl U, Hoffmann F, Michalski D, Pfeilschifter W, Urbanek C, Petzold GC, Rizos T, Kraft A, Haeusler KG. Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study. Eur Stroke J. 2023 Mar;8(1):241-250. doi: 10.1177/23969873221143856. Epub 2023 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.', 'detailedDescription': 'The purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischaemic stroke and intravenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis, relatives (1st or 2nd degree) of patients with acute ischaemic stroke, patient with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis and patients without acute ischaemic stroke (admitted to the Department of Cardiology (Charité, Campus Benjamin Franklin, Germany).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria (all):\n\n* age ≥18 years\n* able to give informed consent\n* ability to understand and read German\n* no prior i.v.-thrombolysis\n\nAdditional inclusion criteria - patients with acute ischaemic stroke:\n\n* suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke\n* indication for intravenous thrombolysis\n\nAdditional inclusion criteria - relatives:\n\n· relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure\n\nAdditional inclusion criteria - stroke patients with a contraindication for thrombolysis:\n\n* ischaemic stroke (according to brain MRI or CT)\n* contraindication for intravenous thrombolysis\n\nAdditional inclusion criteria - non-stroke patients:\n\n· present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany\n\nExclusion criteria (all groups):\n\n* not able to give imformed consent or under legal supervision/guardianship\n* participation in an interventional study'}, 'identificationModule': {'nctId': 'NCT03246256', 'briefTitle': 'Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'EA4/140/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure', 'interventionNames': ['Other: Group 1']}, {'label': 'Group 2', 'description': '1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure', 'interventionNames': ['Other: Group 1']}, {'label': 'Group 3', 'description': 'Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis', 'interventionNames': ['Other: Group 1']}, {'label': 'Group 4', 'description': 'Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)', 'interventionNames': ['Other: Group 1']}, {'label': 'Group 5', 'description': 'Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure', 'interventionNames': ['Other: Group 1']}], 'interventions': [{'name': 'Group 1', 'type': 'OTHER', 'otherNames': ['Group 2', 'Group 3', 'Group 4', 'Group 5'], 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Neurology, University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Neurology, University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Department of Neurology, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Ludwigshafen am Rhein', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen a. Rh.', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Neurology, Charité - Universitätsmedizin Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Neurologist', 'investigatorFullName': 'Karl Georg Haeusler', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}