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临床试验/NCT06348459
NCT06348459招募中不适用

Registry of Catheter Intervention in Pulmonary Embolism

Hospital San Carlos, Madrid1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
All cause-death

研究概览

简要总结

Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.

研究设计

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

入排标准

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

入选标准

  • adult patients (aged 18 years old or older)
  • confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
  • high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers [troponin or N-terminal pro-B-type natriuretic peptide], and right ventricle to left ventricle ratio > 0.9 [on computed tomography or echocardiogram], and PE severity index III to IV or simplified PE severity index=1
  • eligibility for catheter-directed intervention

排除标准

  • unconfirmed diagnosis of PE
  • undefined risk stratification, and
  • PE with uncertain chronology or beyond seven days of symptom initiation.

结局指标

主要结局

All cause-death

时间窗: during hospital admission (up to day 10)

次要结局

  • all cause-death(2 year)
  • procedural success(48 hours)
  • in-hospital complications(during hospital admission (up to day 10))

研究者

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

Pablo Salinas

MD, PhD

Hospital San Carlos, Madrid

研究点 (1)

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