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Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients. (VSU)

2026年6月16日 更新者：Hospital Universitario Virgen Macarena

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

726

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
其他：(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.
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.
其他：Conventional care
Bundle of conventional stroke unit care

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Death or dependency at 90 days (modified Rankin Scale 3-6)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Adherence to the stroke-unit care quality bundle
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：Index admission
Length of index admission in days, from admission to discharge
Index admission

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospital Universitario Virgen Macarena

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月1日

初级完成 (估计的)

2027年3月31日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PI24/01807

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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