Ambulatory Stroke Unit Treatment for Elderly Patients (ARTIFICE)

University Hospital Heidelberg

Status: Enrolling

Conditions: Ischemic Stroke; Retinal Ischemia; Transient Ischemic Attack (TIA)

Treatments: Other: Ambulatory Stroke Unit Care; Other: Conventional Stroke Unit Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07420374

01NVF24306 (Other Grant/Funding Number)

S-689/2025 (ARTIFICE)

Details and patient eligibility

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.

Full description

Stroke unit treatment in Germany is currently organized as multi-day inpatient care regardless of stroke severity. However, a substantial proportion of patients with acute ischemic stroke or transient ischemic attack present with non-disabling or fully regressed neurological deficits and may not require prolonged inpatient monitoring. At the same time, demographic changes and increasing stroke incidence in older populations challenge inpatient stroke unit capacity and resource allocation.

International experience with structured outpatient TIA and minor stroke clinics suggests that ambulatory management models may provide comparable clinical safety while reducing hospital utilization. However, randomized evidence for such models within the German healthcare system is lacking.

The ARTIFICE trial evaluates a structured ambulatory stroke unit care model designed to provide comprehensive same-day multiprofessional assessment and initiation of secondary prevention while maintaining patient safety. The study investigates whether this ambulatory care approach can represent a medically safe and resource-efficient alternative to conventional inpatient stroke unit treatment in selected older patients.

In addition to clinical effectiveness, the study examines patient-reported outcomes, healthcare utilization, cost-effectiveness, and implementation aspects to inform future health services planning.

Enrollment: 400 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

400 participants in 2 patient groups

Ambulatory Stroke Unit Care (aSU)

Experimental group

Description:

Participants receive structured ambulatory stroke unit care consisting of comprehensive same-day multiprofessional assessment, diagnostic evaluation, and initiation of secondary prevention. After evaluation, clinically stable participants are discharged home with structured follow-up.

Treatment:

Other: Ambulatory Stroke Unit Care

Inpatient Stroke Unit Care (SU)

Active Comparator group

Description:

Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission.

Treatment:

Other: Conventional Stroke Unit Care