Same-day ambulatory stroke unit care for older adults with minor stroke or TIA
Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
NA · University Hospital Heidelberg · NCT07420374
This trial will try whether same-day ambulatory stroke unit care works as well as inpatient stroke unit care for people aged 60 and older with minor ischemic stroke, transient ischemic attack, or retinal ischemia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT07420374 on ClinicalTrials.gov |
What this trial studies
ARTIFICE is a multicenter, randomized, controlled non-inferiority trial that assigns eligible patients 1:1 to either a same-day ambulatory multiprofessional stroke evaluation (ambulatory stroke unit, aSU) or guideline-based inpatient stroke unit care (SU). The primary outcome is favorable functional status at 90 days, defined as modified Rankin Scale (mRS) 0–2 or return to pre-stroke mRS, with blinded endpoint assessment using a PROBE design. Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness, and a mixed-methods process evaluation examines implementation feasibility. The ambulatory model focuses on delivering comprehensive same-day diagnostics and initiation of secondary prevention while monitoring safety in selected older patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 years or older with acute ischemic stroke, transient ischemic attack, or retinal ischemia within 7 days of onset who have no or only non-disabling new neurological deficits and can safely undergo ambulatory management and provide informed consent.
Not a fit: Patients who require urgent surgical or interventional procedures, have fluctuating symptoms, clinically relevant dysphagia, active infectious isolation needs, other critical medical or nursing needs, or are in a palliative situation are unlikely to benefit from ambulatory management and should remain inpatient.
Why it matters
Potential benefit: If successful, eligible patients could receive comprehensive same-day stroke care outside an inpatient stay, potentially reducing hospital admissions, patient burden, and health-care resource use while maintaining clinical outcomes.
How similar studies have performed: Structured outpatient TIA and minor stroke clinics internationally have suggested comparable clinical safety and reduced hospital use, but randomized evidence for ambulatory stroke unit models within the German healthcare system has been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Heidelberg
- Heidelberg University Hospital — Heidelberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Jan C Purrucker, Prof. Dr.
- Email: artifice.studie@med.uni-heidelberg.de
- Phone: +49 6221 56 6999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Transient Ischemic Attack, Retinal Ischemia, Ambulatory Stroke Unit, Stroke Unit Care, Minor Stroke, Geriatric Stroke, Non-Inferiority Trial