Same-day ambulatory stroke unit care for older adults with minor stroke or TIA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.