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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID07420374

Evaluating Ambulatory Stroke Unit Care Compared to Inpatient Stroke Unit Treatment for Patients Aged 60 and Older with Acute Ischemic Stroke or Related Conditions

Led by University Hospital Heidelberg · Updated on 2026-03-31

400

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University Hospital Heidelberg

Lead Sponsor

H

Heinrich-Heine University, Duesseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether an ambulatory stroke unit model aSU is not worse than conventional inpatient stroke unit care SU for patients aged 60 years or older who have had an acute ischemic stroke, transient ischemic attack TIA, or retinal ischemia with mild or no lasting neurological problems. This study aims to see if outpatient care can be a medically safe and resource-efficient alternative to hospital care in managing these types of strokes in older adults, with attention to clinical outcomes, patient quality of life, and health care use. Participants are randomly assigned to one of two groups. One group receives ambulatory stroke unit care involving a comprehensive same-day multiprofessional assessment, diagnostic evaluation, and start of secondary prevention treatments, followed by discharge home if stable. The other group receives standard inpatient stroke unit care with hospital admission, monitoring, and diagnostics according to clinical guidelines. The main comparison is based on patients functional outcome 90 days after treatment. During the 90-day study period, researchers evaluate functional status using the modified Rankin Scale, monitor for early neurological worsening, recurrent strokes, delirium, mortality, and serious adverse events. They also assess health-related quality of life, mobility, stroke impact, healthcare use, and treatment costs. Outcome assessments are done by blinded evaluators, and some measurements continue up to 12 months. The study explores the feasibility and acceptance of ambulatory stroke care to inform future health service planning.

CONDITIONS

Brief Title

Ambulatory Stroke Unit Treatment for Elderly Patients

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Diagnosis of acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia
  • Stroke symptoms started within 7 days before enrollment
  • No or non-disabling newly occurring neurological deficits allowing safe outpatient care
  • Written informed consent provided by participant or authorized representative
Not Eligible

You will not qualify if you...

  • Need for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
  • Fluctuating stroke symptoms within the previous 48 hours
  • Acute fever or infectious disease requiring isolation
  • Significant swallowing difficulties with high risk of aspiration
  • Critical medical or nursing conditions requiring mandatory inpatient treatment
  • Receiving palliative care with limited acute diagnostics or therapy
  • Previous participation in ambulatory stroke unit care model
  • No statutory health insurance coverage in Germany
  • Insufficient German language skills to understand study procedures and assessments

Research Team

J

Jan C Purrucker, Prof. Dr.

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