RecruitingNot ApplicableNCT07635498

Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study

Sponsor

Hospital Universitario Virgen Macarena

Enrollment

726 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Stroke Ischemic Stroke Stroke Hemorrhagic

Summary

Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct access to an SU, particularly those not eligible for mechanical thrombectomy who are admitted to regional or district hospitals without on-site SU capacity. The Virtual Stroke Unit (VSU) concept extends specialized stroke care to non-SU hospitals by combining standardized in-hospital monitoring boxes with synchronous remote multidisciplinary assessment by a stroke neurologist and stroke nurse from a reference center, via the regional telemedicine platform (CATI). This prospective, multicenter, non-inferiority cohort study compares effectiveness, safety, and feasibility of VSU care versus conventional SU care in patients with acute ischemic or hemorrhagic stroke who are not candidates for mechanical thrombectomy. Recruitment targets 363 patients per arm (726 total). The primary outcome is death or dependency at 3 months (modified Rankin Scale 3-6) - the canonical measure of stroke-unit effectiveness - with functional independence (mRS 0-2), adherence to the stroke-unit care quality bundle, safety, mortality, recurrence, length of stay, satisfaction (TUQ/TSQ/TMPQ) and cost-effectiveness as secondary outcomes.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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).

Exclusion Criteria5

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.

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Interventions

OTHER(Healthcare organizational model)

Structured multidisciplinary stroke care delivered remotely from the reference Stroke Unit (Hospital Universitario Virgen Macarena) to non-SU hospitals (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe). Components: (i) standardized stroke monitoring boxes with predefined nursing protocols; (ii) synchronous joint assessment between local team and reference stroke neurologist/nurse via CATI videoconferencing on day 1 of admission; (iii) structured remote follow-up during hospitalization; (iv) standardized teleconsultation discharge report; (v) protocolized scheduled remote re-assessment at 1 week, 1 month, 3 months and 12 months.

OTHERConventional care

Bundle of conventional stroke unit care