跳至主要内容
临床试验/NCT06645405
NCT06645405招募中不适用

Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial

Shanghai Jiao Tong University Affiliated Sixth People's Hospital3 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
174
试验地点
3
主要终点
AFAT

研究概览

简要总结

Acute ischemic stroke (AIS) caused by intracranial large vessel occlusion (LVO) in the anterior circulation significantly contributes to stroke-related disability and mortality. Recent randomized controlled trials have demonstrated substantial benefits of endovascular thrombectomy (EVT) when patients are appropriately triaged beforehand. However, accurately orienting the 'missed segment' during EVT remains challenging. Guide-wires often fail to navigate through the occlusion or are mistakenly directed into the small tranches or even cause vessel rupture. To address this clinical need, the investigators developed an artificial intelligence (AI) algorithm to automate the reconstruction of CT angiography (CTA), focusing on the occluded LVO segment. To evaluate the clinical utility of this AI algorithm, the investigators propose a prospective, stepped-wedge cluster-randomized study to determine whether integrating our AI algorithm into AIS care flow can reduce the time for first pass of the thrombus by improving the visualization of the occluded segment on CTA. Physicians will assess patient eligibility for thrombectomy, and all selected patients will receive standard care according to current guidelines. This approach is expected to enhance patient treatment outcomes for endovascular thrombectomy by leveraging readily available data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female, 18 years of age or older.
  • Patients who present with signs and/or symptoms concerning acute ischemic stroke.
  • Patients who undergo noncontrast CT and CT angiography imaging.
  • Patients determined to have an intracranial large vessel occlusion (including the internal carotid artery, middle cerebral artery M1 segment, and M2 segment), and eligible for endovascular treatment.

排除标准

  • CT imaging with severe motion artifacts.

结局指标

主要结局

AFAT

时间窗: Immediately after EVT

The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time \[AFAT\])

次要结局

  • PRT(Immediately after EVT)
  • IPT(Immediately after EVT)
  • IRT(Immediately after EVT)
  • The rate of successful flow restoration immediately after EVT(Immediately after EVT)
  • The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT(24 hours post-EVT)
  • The rate of procedure-related complications(Immediately after EVT)
  • The rate of functional independence at 90 days post-EVT(90 days post-EVT)
  • The mortality rate within 90 days post-EVT(90 days post-EVT)

研究者

发起方
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yueqi Zhu

MD

Shanghai 6th People's Hospital

研究点 (3)

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