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

June 3, 2026 updated by: Hospital Universitario Virgen Macarena

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. Stroke Units reduce mortality and dependence in acute stroke patients regardless of stroke subtype, severity, age or sex. However, in Andalusia, only a small proportion of acute stroke patients are admitted to an SU; many patients who are not candidates for mechanical thrombectomy remain hospitalized in non-SU wards of regional hospitals, with limited access to structured stroke-specific multidisciplinary care.

Rationale. Telemedicine-supported organizational models have shown promise to bridge the access gap for time-sensitive stroke care. The Virtual Stroke Unit (VSU) is a novel organizational model that combines (i) standardized monitoring boxes in non-SU hospitals with predefined nursing protocols, (ii) a daily synchronous joint visit between the local team and the reference SU team via the CATI telemedicine platform, and (iii) structured remote follow-up and discharge planning. The VSU model has not been formally evaluated in a comparative prospective study.

Objectives. Primary: to test whether VSU care is non-inferior to conventional SU care for 3-month functional outcome (mRS) in patients with acute stroke not eligible for mechanical thrombectomy. Secondary: to evaluate safety (in-hospital complications, mortality), efficiency (length of stay, inter-hospital transfers), patient and provider satisfaction (TUQ/TSQ/TMPQ), 1-year functional outcome and recurrence, and cost-effectiveness.

Design. Prospective multicenter cohort study with two parallel groups:

  • VSU group: consecutive eligible patients admitted to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos), receiving structured remote care from the CATI/Virgen Macarena stroke team.
  • Conventional SU group (control): consecutive eligible patients admitted to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla), without telemedicine support.

Sample size. 363 patients per group (726 total) to detect non-inferiority of VSU vs SU on the primary outcome, with a non-inferiority margin of 10%, 80% power, two-sided α = 5%, and an estimated 15% loss to follow-up.

Study Type

Interventional

Enrollment (Estimated)

726

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Virtual Stroke Unit (VSU)
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)
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.
Active Comparator: Group 2 - Conventional Stroke Unit (Control)
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
Bundle of conventional stroke unit care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or dependency at 90 days (modified Rankin Scale 3-6)
Time Frame: 90 days from index admission
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the stroke-unit care quality bundle
Time Frame: Index admission
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.
Index admission
In-hospital complications (composite safety endpoint)
Time Frame: Index admission (median 7-10 days)
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.
Index admission (median 7-10 days)
Etiological classification (TOAST)
Time Frame: 3 months
Distribution of TOAST etiological categories in ischemic strokes (large-artery atherosclerosis, cardioembolic, small-vessel, other determined, undetermined).
3 months
Adherence to secondary prevention
Time Frame: 3 and 12 months
Proportion of participants on guideline-concordant secondary prevention (antithrombotic therapy, antihypertensives, statins, anticoagulation if indicated) at 3 and 12 months.
3 and 12 months
Length of hospital stay
Time Frame: Index admission
Length of index admission in days, from admission to discharge
Index admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen Macarena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI24/01807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing of individual participant data (IPD) is not currently planned. Aggregated study results will be disseminated through peer-reviewed publications and scientific congresses. Requests for de-identified IPD may be considered on a case-by-case basis subject to data protection regulations (GDPR), ethical approval and a formal data-sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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