Actively Recruiting
Ambulatory Stroke Unit Treatment for Elderly Patients
Led by University Hospital Heidelberg · Updated on 2026-03-31
400
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
H
Heinrich-Heine University, Duesseldorf
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ambulatory Stroke Unit Treatment for Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Diagnosis of acute ischemic stroke, transient ischemic attack, or retinal ischemia
- Symptom onset within 7 days before enrollment
- No or non-disabling new neurological deficits allowing safe outpatient care
- Written informed consent by participant or authorized representative
You will not qualify if you...
- Need for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
- Fluctuating stroke symptoms within the past 48 hours
- Acute febrile infection or infectious disease requiring isolation
- Significant swallowing problems with high risk of aspiration
- Medical or nursing conditions requiring mandatory inpatient treatment
- Palliative care with limits on acute diagnostics or therapy
- Previous participation in the ambulatory stroke unit care model
- Lack of statutory health insurance coverage in Germany
- Insufficient German language skills to understand study procedures and assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Heidelberg University Hospital
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
J
Jan C Purrucker, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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