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Clinical Trials/NCT04020250
NCT04020250
Unknown
Not Applicable

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

Assiut University0 sites30 target enrollmentAugust 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Embolism
Sponsor
Assiut University
Enrollment
30
Primary Endpoint
the need for rescue thrombolysis in initially normotensive Acute pulmonary embolism patients.
Last Updated
6 years ago

Overview

Brief Summary

  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.

Detailed Description

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 .

Registry
clinicaltrials.gov
Start Date
August 2019
End Date
September 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rofaida Raafat Talaat Ibrahim

Principle Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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.

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