Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients. (NCT07635498) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients.
Spain726 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Death or dependency at 90 days (modified Rankin Scale 3-6)