NCT07420374 Ambulatory Stroke Unit Treatment for Elderly Patients
| NCT ID | NCT07420374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-03-25 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07420374 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07420374 currently recruiting?
Yes, NCT07420374 is actively recruiting participants. Contact the research team at artifice.studie@med.uni-heidelberg.de for enrollment information.
Where is the NCT07420374 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT07420374 clinical trial?
NCT07420374 is sponsored by University Hospital Heidelberg. The trial plans to enroll 400 participants.
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