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

NCT07635498 | Recruiting

• 1 other identifier: PI24/01807
• Study Type: interventional
• Target: 726
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Hemorrhagic; Ischemic Stroke

Keywords

Virtual Stroke Unit; Telemedicine; Telestroke; Stroke Unit; Healthcare delivery system; Non-inferiority; Modified Rankin Scale

Outcome Measures

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.

  90 days from index admission

Secondary Outcomes (5)

• Adherence to the stroke-unit care quality bundle

  Index admission

• In-hospital complications (composite safety endpoint)

  Index admission (median 7-10 days)

• Etiological classification (TOAST)

  3 months

• Adherence to secondary prevention

  3 and 12 months

• Length of hospital stay

  Index admission

Study Arms (2)

Group 1 - Virtual Stroke Unit (VSU)

EXPERIMENTAL

Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos, Sevilla). Care is delivered in standardized monitoring boxes following an SU-equivalent nursing protocol, with daily synchronous joint assessment by the reference stroke team (Hospital Universitario Virgen Macarena) via the CATI telemedicine platform.

Other: (Healthcare organizational model)

Group 2 - Conventional Stroke Unit (Control)

ACTIVE COMPARATOR

Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla). Care is delivered in person by the local SU multidisciplinary team without telemedicine support.

Other: Conventional care

Interventions

(Healthcare organizational model) OTHER

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.

Group 1 - Virtual Stroke Unit (VSU)

Conventional care OTHER

Bundle of conventional stroke unit care

Group 2 - Conventional Stroke Unit (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Hospital San Juan de Dios, Bormujos

Seville, Spain

RECRUITING

Related Publications (3)

• Behrens JR, Kaffes M, Aigner A, Herm J, Erdur H, Siepmann T, Barlinn J, Hubert G, Wiestler H, Gumbinger C, Ranta A, von Weitzel-Mudersbach P, Rocco A, Hofmann-Shen C, Muhn F, Liman T, Rozanski M, Litmeier S, Riegler C, Hellwig S, Geran R, Koschutzke L, Ditsche H, Kotlarz-Bottcher M, Kinze S, Audebert H. Teleneurology vs On-Site Neurology Consultation for Postadmission Hospital Care of Stroke. JAMA Neurol. 2026 Apr 6:e260615. doi: 10.1001/jamaneurol.2026.0615. Online ahead of print.

  PMID: 41941227 BACKGROUND

• Martins SO, Feigin V, Carbonera LA, de Souza AC, Secchi TL, Nair B, Sposato LA, Liu L, Molina CA, Nogueira RG. Integrating Digital Health Into Stroke Policies. Stroke. 2026 Jun;57(6):1796-1809. doi: 10.1161/STROKEAHA.125.050451. Epub 2026 Mar 30.

  PMID: 41906872 BACKGROUND

• Barragan-Prieto A, Perez-Sanchez S, Moniche F, Moyano RV, Delgado F, Martinez-Sanchez P, Moya M, Oropesa JM, Minguez-Castellanos A, Villegas I, Alvarez Soria MJ, Tamayo Toledo JA, de la Cruz Cosme C, Canto Neguillo R, Herrerias Esteban JM, Montero Cobos DJ, Moreno Munoz JA, Gonzalez A, Montaner J. Express improvement of acute stroke care accessibility in large regions using a centralized telestroke network. Eur Stroke J. 2022 Sep;7(3):259-266. doi: 10.1177/23969873221101282. Epub 2022 May 25.

  PMID: 36082245 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

ES (1)