Condition or disease | Intervention/treatment |
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Pulmonary Embolism | Device: Echocardiography |
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 |
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 |
Tracking Information | |||||||||
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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 |
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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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 |
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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 . |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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) |
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Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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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 |