Ambulatory Stroke Unit Treatment for Elderly Patients

NCT07420374 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2026-03-25

Last updated

2026-03-31

Condition(s) studied

Ischemic StrokeTransient Ischemic Attack (TIA)Retinal Ischemia

Investigational drug(s) / intervention(s)

Ambulatory Stroke Unit CareConventional Stroke Unit Care

Ambulatory Stroke Unit Care: Structured ambulatory stroke care model providing same-day neurological assessment, diagnostic work-up, therapeutic evaluation, and multidisciplinary case review, followed by discharge home if medically appropriate.

Conventional Stroke Unit Care: Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.

Study summary

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.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

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

Primary outcome measure(s)

Favorable Functional Outcome at 90 Days — 90 days (±14 days) after randomization
Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors.

Trial sites (1)

Facility	City	Region	Status
Heidelberg University Hospital	Heidelberg	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420374 on ClinicalTrials.gov ↗ ← All trials in Germany