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临床试验/NCT04879069
NCT04879069招募中不适用

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2018年6月1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
10,000
试验地点
1
主要终点
Ventricular strain reduction

研究概览

简要总结

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

详细描述

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic "obstructive" collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres.

The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome.

The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • PE confirmed by computed tomography pulmonary angiography.
  • PE symptoms duration ≤ 14 days.
  • High-risk PE with hemodynamic instability (one of):
  • cardiac arrest
  • obstructive shock
  • persistent hypotension.
  • Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.

排除标准

  • Refusal to sign the informed consent form.

结局指标

主要结局

Ventricular strain reduction

时间窗: 24 hours after specific PE treatment implementation

Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography

Clinical improvement during hospitalization

时间窗: 24 hours after specific PE treatment implementation

Incidence of arterial blood saturation increase \>92%

Early mortality rate from pulmonary embolism

时间窗: Two weeks since PE diagnosis

Number of patients who died from pulmonary embolism (right heart failure)

次要结局

  • Total mortality rate from pulmonary embolism(3 months since PE diagnosis)
  • Bleeding events incidence(3 months since PE diagnosis)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksander Araszkiewicz

Professor of Medicine

Poznan University of Medical Sciences

研究点 (1)

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