Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitario Virgen Macarena
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
(Healthcare organizational model)
Other interventionStructured 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.
Conventional care
Other interventionBundle of conventional stroke unit care
Treatment groups
726 Participants
are divided into 2 treatment groupsGroup A: Group 1 - Virtual Stroke Unit (VSU)1 intervention
Group B: Group 2 - Conventional Stroke Unit (Control)1 intervention
Trial outcomes
Primary outcomes
1
Death or dependency at 90 days (modified Rankin Scale 3-6)
Proportion of participants who are dead or functionally dependent (mRS 3-6) at 90 ± 15 days post-admission. The mRS is a 7-level clinician-rated scale (0 = no symptoms; 6 = death); the 3-6 range is the canonical measure of stroke-unit effectiveness (avoidance of death or dependency). Non-inferiority of VSU versus conventional SU care is declared if the upper limit of the one-sided 95% confidence interval for the between-group difference does not exceed the pre-specified +10 percentage-point margin.
Time frame
90 days from index admissionSecondary outcomes
1
Adherence to the stroke-unit care quality bundle
Proportion of participants receiving a predefined stroke-unit care bundle during the index admission, equivalent to conventional SU standards: dysphagia screening before oral intake, early mobilization, neurological/vital-sign monitoring protocol, antithrombotic therapy within 48 h when indicated, and structured multidisciplinary assessment. Measures whether VSU care reproduces the quality of conventional stroke-unit care.
Time frame
Index admission2
In-hospital complications (composite safety endpoint)
Composite of in-hospital medical complications: symptomatic intracranial hemorrhage, early neurological worsening (NIHSS ≥ 4 points), aspiration pneumonia, deep vein thrombosis, urinary tract infection, in-hospital death.
Time frame
Index admission (median 7-10 days)3
Etiological classification (TOAST)
Distribution of TOAST etiological categories in ischemic strokes (large-artery atherosclerosis, cardioembolic, small-vessel, other determined, undetermined).
Time frame
3 months4
Adherence to secondary prevention
Proportion of participants on guideline-concordant secondary prevention (antithrombotic therapy, antihypertensives, statins, anticoagulation if indicated) at 3 and 12 months.
Time frame
3 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov