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Artificial Intelligence Support for Stroke

2026年8月26日 更新者：Ji Xunming,MD,PhD、Capital Medical University

Artificial Intelligence-Assisted Decision Support for Intravenous Thrombolysis in Acute Ischemic Stroke at Basic Hospitals in China (ASSIST)

This study investigates whether an AI-assisted decision support tool, compared with standard care, increases the proportion of acute ischemic stroke patients receiving intravenous thrombolysis within 24 hours of symptom onset at a primary hospital in China, while also evaluating its impact on clinical outcomes, treatment timelines, and safety.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This single-center, randomized controlled, open-label, blinded-endpoint trial aims to evaluate whether an AI-assisted decision support tool increases the proportion of acute ischemic stroke patients (onset <24 h) receiving intravenous thrombolysis at a primary hospital in China, and to assess its impact on clinical outcomes. Using cluster randomization at the level of attending physicians , the intervention group adds the AI tool to routine assessment, while the control group follows current guidelines and standard institutional protocols; both groups are not permitted to delay routine care for research purposes.

研究类型

介入性

注册 (估计的)

516

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。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Hunan
      • Changsha、Hunan、中国
        • 招聘中
        • Liuyang Jili Hospital
        • 接触：
          • Yong He
          • 电话号码：073183615622

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

描述

Inclusion Criteria:

  1. Age ≥18 years.
  2. Clinical diagnosis of acute ischemic stroke.
  3. Onset time (last known well) <24 hours.
  4. CT or MRI examination excluding intracerebral hemorrhage.
  5. Signed informed consent by the patient or a legally authorized representative

Exclusion Criteria:

  1. Currently participating in another interventional clinical trial related to drugs or devices.
  2. Pregnant women.
  3. Has received intravenous thrombolysis at another hospital.
  4. Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.

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

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：AI-Assisted Group
Patients receive care from attending physicians who use the AI-assisted thrombolysis decision support tool in addition to routine assessment, with the final treatment decision left to the physician's clinical judgment.
其他：AI-assisted thrombolysis decision support
The AI-assisted thrombolysis decision support tool is used by attending physicians in addition to routine stroke evaluation. After the physician enters key patient data, the system generates real-time prompts on whether the patient meets criteria for intravenous thrombolysis, recommended additional tests and risk alerts for thrombolysis. The final treatment decision remains with the treating clinician.
无干预：Standard Treatment Group
Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The proportion of patients receiving intravenous thrombolysis.
大体时间：24 hours within last known well
24 hours within last known well

次要结果测量

结果测量
措施说明
大体时间
Proportion of patients with an modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability) of 0-1 at 90 days
大体时间：90 days after stroke onset
90 days after stroke onset
90-Day modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability)
大体时间：90 days after stroke onset
90 days after stroke onset
Early neurological improvement
大体时间：24 hours after admission
Defined as an improvement of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS, 0-42 score, a higher score indicates a more severe condition) score within 24 hours, or a score of 0.
24 hours after admission
Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis
大体时间：24 hours within last known well
24 hours within last known well

其他结果措施

结果测量
大体时间
Proportion of symptomatic intracranial hemorrhage within 36 hours of thrombolysis
大体时间：within 36 hours of thrombolysis
within 36 hours of thrombolysis
Proportion of any type of intracranial hemorrhage within 36 hours of thrombolysis
大体时间：within 36 hours of thrombolysis
within 36 hours of thrombolysis
90-day all-cause mortality rate.
大体时间：90 days after stroke onset
90 days after stroke onset

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

Capital Medical University

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8月26日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年8月15日

首先提交符合 QC 标准的

2026年8月23日

首次发布 (实际的)

2026年8月25日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8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

  • ASSIST

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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