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Ambulatory Stroke Unit Treatment for Elderly Patients

RecruitingNAAges 60 Years - anyAllUniversity Hospital Heidelberg
NCT07420374 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • Ambulatory Stroke Unit Care
  • Conventional Stroke Unit Care
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Where

1 site
Heidelberg University Hospital
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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