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临床试验/NCT05299034
NCT05299034已完成不适用

Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 2,173 人开始时间: 2022年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,173
试验地点
1
主要终点
mRS at 90 days

研究概览

简要总结

We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:

  1. To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.
  2. To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.
  3. To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in >6h from the onset of symptoms.

METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases

  1. retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.
  2. validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.

Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

mRS at 90 days

时间窗: 90 days after stroke

Percentage of patients with functional independence, defined as mRS \< or =2 on day 90 as assessed centrally by blinded evaluators of the Catalan Stroke Master Plan.

Rate of patients treated with mechanical thrombectomy

时间窗: less than 24 hours after the diagnostic test

次要结局

  • Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points(From 24 to 72 hours after stroke)
  • Mortality at discharge and at day 90(90 days after stroke)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Hernández Pérez

MD, PhD

Germans Trias i Pujol Hospital

研究点 (1)

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