Ambulatory Stroke Unit Treatment for Elderly Patients
Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
University Hospital Heidelberg
400 participants
Mar 25, 2026
INTERVENTIONAL
Conditions
Summary
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. Eligible 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). Secondary 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.
Eligibility
Inclusion Criteria5
- Age ≥ 60 years
- Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.\*)
- Symptom onset ≤ 7 days before enrollment
- No or non-disabling newly occurring neurological deficit allowing safe ambulatory management
- Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative
Exclusion Criteria9
- Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
- Fluctuating stroke symptoms within the previous 48 hours
- Acute febrile infection or isolation-requiring infectious disease
- Clinically relevant dysphagia with high aspiration risk
- Critical medical or nursing findings requiring mandatory multi-day inpatient treatment
- Palliative care situation with limitation of acute diagnostic or therapeutic measures
- Previous participation in the ambulatory stroke unit care model
- No statutory health insurance coverage in Germany
- Insufficient German language proficiency to understand study procedures and assessments
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Interventions
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.
Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.
Locations(1)
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NCT07420374