跳至主要内容
临床试验/NCT04020250
NCT04020250Unknown不适用

Echocardiographic Parameters in Predicting Outcome in Patients With Intermediate - Risk Pulmonary Embolism

Assiut University0 个研究点目标入组 30 人开始时间: 2019年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
the need for rescue thrombolysis in initially normotensive Acute pulmonary embolism patients.

研究概览

简要总结

  1. To analyze the diagnostic and prognostic value of echocardiographic parameters.
  2. Prediction of APE-related 30-day mortality and adverse out comes.
  3. The need for rescue thrombolysis in initially normotensive Acute pulmonary embolism (APE) patients.

详细描述

Acute pulmonary embolism (APE) is the most serious clinical presentation of venous thromboembolism (VTE). According to registries and hospital discharge databases of unselected patients with Acute pulmonary embolism and venous thromboembolism , 30-day all-cause mortality rates are between 9% and 10%.

According to the recent European Society of Cardiology (ESC) guidelines on the diagnosis and treatment of Acute pulmonary embolism patients, clinical classification of the severity of an episode of Acute pulmonary embolism is based on the estimated 30-day Acute pulmonary embolism - related mortality risk. Patients with cardiogenic shock caused by Acute pulmonary embolism comprise a high-risk group for early death, which is estimated at more than 15%.

Fortunately most Acute pulmonary embolism patients are hemodynamically stable at admission but the early mortality risk is different in this population. Risk stratification of non-high-risk Acute pulmonary embolism patients is based on clinical presentation, cardiac laboratory biomarkers, and signs of right ventricular (RV) dysfunction on echocardiography or computed tomography. Low-risk patients require a short hospital stay and can be early discharged home or even treated as outpatients.

Intermediate-risk subjects comprise a very heterogeneous group in which the early mortality ranges between 2% and 15%. More of these patients stabilize hemodynamically during anticoagulation, but in some of them clinical deterioration occurs and therefore they may require rescue thrombolysis or surgical or percutaneous embolectomy.

Echocardiography is a useful diagnostic tool to detected right ventricular (RV) dysfunction. It was reported that tricuspid annulus plane systolic excursion (TAPSE) can be used for risk stratification of normotensive APE patients. The tricuspid regurgitation peak gradient (TRPG) is an echocardiographic sign of RV overload and it can also be used for risk stratification in 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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and <70 years.
  • Patients with intermediate- risk pulmonary embolism will be
  • hemodynamically stable at admission with systolic blood pressure
  • 90 mmHg and without signs of peripheral hypoperfusion.
  • elevated cardiac biomarkers levels (particularly, a positive cardiac troponin test

排除标准

  • 1- Age <18 years.
  • 2- Patients diagnosed with chronic thromboembolic hypertension.
  • 3- Patients with valvular heart diseases.
  • 4- Patients with lung cancer.
  • 5- Acute massive pulmonary embolism.

结局指标

主要结局

the need for rescue thrombolysis in initially normotensive Acute pulmonary embolism patients.

时间窗: one month

analyses the diagnostic and prognostic value of a new echocardiographic parameter, TRPG/ TAPSE, for prediction of APE-related 30-day death or the need for rescue thrombolysis in initially normotensive Acute pulmonary embolism patients.

次要结局

未报告次要终点

研究者

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

Rofaida Raafat Talaat Ibrahim

Principle Investigator

Assiut University

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