NCT07635498 Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients.
| NCT ID | NCT07635498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario Virgen Macarena |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 726 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 726 participants in total. It began in 2026-04-01 with a primary completion date of 2027-03-31.
⚠ 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
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
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.
Frequently Asked Questions
Who can join the NCT07635498 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07635498 currently recruiting?
Yes, NCT07635498 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Universitario Virgen Macarena to inquire about joining.
Where is the NCT07635498 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07635498 clinical trial?
NCT07635498 is sponsored by Hospital Universitario Virgen Macarena. The trial plans to enroll 726 participants.
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