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出境医 / 临床实验 / Role of Echocardiography in Pulmonary Embolism

Role of Echocardiography in Pulmonary Embolism

Study Description
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.

Condition or disease Intervention/treatment
Pulmonary Embolism Device: Echocardiography

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 .

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiographic Parameters in Predicting Outcome in Patients With Intermediate - Risk Pulmonary Embolism
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 9, 2019
First Posted Date July 16, 2019
Last Update Posted Date July 16, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Echocardiography in Pulmonary Embolism
Official Title Echocardiographic Parameters in Predicting Outcome in Patients With Intermediate - Risk Pulmonary Embolism
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 .

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients diagnosed with pulmonary embolism confirmed by contrast-enhanced multidetector computed tomography (MDCT) when thrombo-emboli were visualized
Condition Pulmonary Embolism
Intervention Device: Echocardiography

Echocardiographic parameters:

Tricuspid annulus plane systolic excursion (TAPSE) Tricuspid regurgitation peak gradient (TRPG)

Study Groups/Cohorts Not Provided
Publications *
  • Bernard S, Namasivayam M, Dudzinski DM. Reflections on Echocardiography in Pulmonary Embolism-Literally and Figuratively. J Am Soc Echocardiogr. 2019 Jul;32(7):807-810. doi: 10.1016/j.echo.2019.05.007.
  • Kanar BG, Şahin A, Göl G, Oğur E, Kavas M, Atas H, Mutlu B. Timing and magnitude of regional right ventricular function and their relationship with early hospital mortality in patients with acute pulmonary embolism. Anatol J Cardiol. 2019 Jun;22(1):26-32. doi: 10.14744/AnatolJCardiol.2019.38906.
  • Kanar BG, Göl G, Oğur E, Kavas M, Ataş H, Mutlu B. Assessment of right ventricular function and relation to mortality after acute pulmonary embolism: A speckle tracking echocardiography-based study. Echocardiography. 2019 Jul;36(7):1298-1305. doi: 10.1111/echo.14398. Epub 2019 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 11, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age >18 and <70 years.
  2. Patients with intermediate- risk pulmonary embolism will be

    1. -hemodynamically stable at admission with systolic blood pressure

      • 90 mmHg and without signs of peripheral hypoperfusion.
    2. - 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rofaida Raafat, MBBch 01099646399 rofaidaraafatchest@gmail.com
Contact: Maha Elkholy, Professor 01096956205 maha_elkholy@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04020250
Other Study ID Numbers Echo in Pulmonary Embolism
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Rofaida Raafat Talaat Ibrahim, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2019