Actively Recruiting
Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
Led by University Hospital Heidelberg · Updated on 2026-03-31
400
Participants Needed
1
Research Sites
13 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
Researchers are evaluating whether an ambulatory stroke unit model (aSU) is not worse than conventional inpatient stroke unit care (SU) for patients aged 60 years or older who have had an acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia with mild or no lasting neurological problems. This study aims to see if outpatient care can be a medically safe and resource-efficient alternative to hospital care in managing these types of strokes in older adults, with attention to clinical outcomes, patient quality of life, and health care use. Participants are randomly assigned to one of two groups. One group receives ambulatory stroke unit care involving a comprehensive same-day multiprofessional assessment, diagnostic evaluation, and start of secondary prevention treatments, followed by discharge home if stable. The other group receives standard inpatient stroke unit care with hospital admission, monitoring, and diagnostics according to clinical guidelines. The main comparison is based on patients' functional outcome 90 days after treatment. During the 90-day study period, researchers evaluate functional status using the modified Rankin Scale, monitor for early neurological worsening, recurrent strokes, delirium, mortality, and serious adverse events. They also assess health-related quality of life, mobility, stroke impact, healthcare use, and treatment costs. Outcome assessments are done by blinded evaluators, and some measurements continue up to 12 months. The study explores the feasibility and acceptance of ambulatory stroke care to inform future health service planning.
CONDITIONS
Brief 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 (TIA), or retinal ischemia
- Stroke symptoms started within 7 days before enrollment
- No or non-disabling newly occurring neurological deficits allowing safe outpatient care
- Written informed consent provided 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 previous 48 hours
- Acute fever or infectious disease requiring isolation
- Significant swallowing difficulties with high risk of aspiration
- Critical medical or nursing conditions requiring mandatory inpatient treatment
- Receiving palliative care with limited acute diagnostics or therapy
- Previous participation in ambulatory stroke unit care model
- No statutory health insurance coverage in Germany
- Insufficient German language skills to understand study procedures and assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days before enrollment
Participants are screened for eligibility to participate in the trial.
Duration - Up to 90 days after enrollment
Participants receive either structured ambulatory stroke unit care with same-day assessment and initiation of secondary prevention followed by discharge home if stable, or guideline-based inpatient stroke unit treatment with hospital monitoring and diagnostic evaluation.
Same-day visit for ambulatory care; inpatient stay duration varies depending on clinical need
Duration - Up to 12 months after enrollment
Participants are monitored for clinical outcomes, neurological status, recurrent stroke, and quality of life through 90 days after enrollment, with some assessments extending up to 12 months.
Follow-up visits up to 90 days, with additional assessments at 12 months
Trial Site Locations
Total: 1 location
1
Heidelberg University Hospital
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
J
Jan C Purrucker, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here