Virtual Stroke Unit care for patients in non-specialized hospitals
Official title: Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study
Run by Hospital Universitario Virgen Macarena · NCT07635498 · Data updated 2026-11-12
This study tests whether delivering stroke care remotely via a Virtual Stroke Unit is as safe and effective as traditional stroke units for adults with acute stroke who aren’t candidates for thrombectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 726 (estimated) |
| Sponsor | Hospital Universitario Virgen Macarena Academic / other |
| Locations | 1 site (Seville) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07635498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with acute ischemic or hemorrhagic stroke admitted to participating non-SU hospitals who are not candidates for mechanical thrombectomy.
✕Probably not a fit
Patients who rapidly deteriorate or have conditions unlikely to improve with stroke-focused care (e.g., very high pre-stroke disability) may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective multicenter cohort compares a telemedicine-enabled Virtual Stroke Unit model with conventional onsite stroke unit care for adults with acute ischemic or hemorrhagic stroke who are not eligible for mechanical thrombectomy. The VSU combines standardized nursing protocols, remote joint assessments by a stroke neurologist and nurse via a regional telemedicine platform, and structured discharge planning. Primary outcomes focus on 3-month functional status (modified Rankin Scale) to determine non-inferiority, with secondary outcomes including safety, length of stay, inter-hospital transfers, satisfaction, longer-term function, recurrence, and cost-effectiveness. The study aims to address access gaps in Andalusia where full SU access is limited.
Why it matters
Potential benefit: If successful, VSU care could expand timely, specialized stroke management to non-SU hospitals, potentially improving outcomes and reducing transfers.
How similar studies have gone: Telemedicine-supported stroke care has shown promise, but the VSU model in non-SU hospital settings is novel and not yet proven in prospective comparative studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age ≥ 18 years. * Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by clinical assessment and neuroimaging (CT and/or MRI) within 24 hours of symptom onset or last-seen-well. * Not a candidate for mechanical thrombectomy according to current clinical guidelines. * Admission to a participating hospital (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe, or Hospital Universitario Virgen Macarena). * Signed informed consent by the participant or legal representative. Exclusion Criteria * Pre-stroke modified Rankin Scale (mRS) ≥ 4. * Life expectancy \< 6 months due to non-stroke comorbid conditions. * Inability to complete protocolized follow-up (geographical, social, or clinical reasons). * Concurrent participation in another interventional clinical trial that may affect study endpoints. * Refusal to provide informed consent.
Where it's running
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Hospital San Juan de Dios, Bormujos
Seville, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.