[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625264":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ambulatory Stroke Unit Care (aSU)","EXPERIMENTAL","Participants receive structured ambulatory stroke unit care consisting of comprehensive same-day multiprofessional assessment, diagnostic evaluation, and initiation of secondary prevention. After evaluation, clinically stable participants are discharged home with structured follow-up.",[13],"Other: Ambulatory Stroke Unit Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Inpatient Stroke Unit Care (SU)","ACTIVE_COMPARATOR","Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission.",[19],"Other: Conventional Stroke Unit Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Ambulatory Stroke Unit Care","Structured ambulatory stroke care model providing same-day neurological assessment, diagnostic work-up, therapeutic evaluation, and multidisciplinary case review, followed by discharge home if medically appropriate.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Stroke Unit Care","Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jan C Purrucker, Prof. Dr.","CONTACT","+49 6221 56 6999","artifice.studie@med.uni-heidelberg.de",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Heidelberg University Hospital","RECRUITING","Heidelberg","69120","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],8.69079,49.40768,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":53},"Dorit Arlt, Dr.","neurologie@med.uni-heidelberg.de",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dr. Jan Christoph Purrucker","Prof. Dr. Jan Purrucker",[59,61],{"name":60,"class":6},"Heinrich-Heine University, Duesseldorf",{"name":62,"class":63},"inav - Institute for Applied Health Services Research GmbH, Berlin, Germany","UNKNOWN","100625264","ambulatory-stroke-unit-treatment-for-elderly-patients-100625264",false,"NCT07420374","Ambulatory Stroke Unit Treatment for Elderly Patients","Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)","ARTIFICE","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.\\*)\n* Symptom onset ≤ 7 days before enrollment\n* No or non-disabling newly occurring neurological deficit allowing safe ambulatory management\n* Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative\n\nExclusion Criteria:\n\n* Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)\n* Fluctuating stroke symptoms within the previous 48 hours\n* Acute febrile infection or isolation-requiring infectious disease\n* Clinically relevant dysphagia with high aspiration risk\n* Critical medical or nursing findings requiring mandatory multi-day inpatient treatment\n* Palliative care situation with limitation of acute diagnostic or therapeutic measures\n* Previous participation in the ambulatory stroke unit care model\n* No statutory health insurance coverage in Germany\n* Insufficient German language proficiency to understand study procedures and assessments","ALL","60 Years",{"count":75,"type":76},400,"ESTIMATED","INTERVENTIONAL",[79],"NA","ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits.\n\nEligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design).\n\nSecondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.",[82,83,84],"Ischemic Stroke","Transient Ischemic Attack (TIA)","Retinal Ischemia",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Ambulatory Stroke Unit","Stroke Unit Care","Minor Stroke","Transient Ischemic Attack","Geriatric Stroke","Non-Inferiority Trial","Health Services Research","Care Delivery Model","Integrated Stroke Care","Post-Stroke Outcome","Modified Rankin Scale","Quality of Life","Cost-Effectiveness","Stroke Recurrence","Delirium","2026-03-25",{"date":103,"type":104},"2026-03-31","ACTUAL",{"date":101,"type":104},{"date":107,"type":76},"2028-12",{"name":5,"class":6},1]