Same-day outpatient stroke care compared with hospital stay in older adults
Compares outpatient with inpatient stroke unit care in older adults after mild stroke.
Plain-language title generated from the registry record
Registry title: Ambulatory Stroke Unit Treatment for Elderly Patients
Key facts
- Where
- Heidelberg, GermanySee the site
Where in Germany
- Heidelberg University HospitalHeidelberg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Heidelberg
- Trial code
- NCT07420374
- Record updated
- 31 March 2026
- Original description
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.Read full original descriptionShow less
Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
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.
Inclusion: 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: Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization); Fluctuating stroke symptoms within the previous 48 hours; Previous participation in the ambulatory stroke unit care model; 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; No statutory health insurance coverage in Germany; Insufficient German language proficiency to understand study procedures and assessments.