CClinicalTrials.gg
Status unknownNCT04020250Updated Jul 16, 2019

Role of Echocardiography in Pulmonary Embolism

An observational study in Pulmonary Embolism, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
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Study 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.
Read the 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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Conditions studied

  • Pulmonary Embolism
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In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's planned enrollment of 30 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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.
      • elevated cardiac biomarkers levels (particularly, a positive cardiac troponin test

Exclusion criteria

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • DeviceEchocardiography

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

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What researchers measure

Primary outcomes

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

    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.

    Time frame: one month

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Study locations

No study locations are listed for this record.

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References and documents

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. No abstract available. PubMed 31272591 ↗
  • Kanar BG, Sahin A, Gol G, Ogur 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. PubMed 31264657 ↗
  • Kanar BG, Gol G, Ogur E, Kavas M, Atas 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. PubMed 31184782 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04020250
Lead sponsor
Assiut University
Responsible party
Rofaida Raafat Talaat Ibrahim (Principle Investigator, Assiut University) — Principal investigator
First posted
Jul 16, 2019
Start date
Aug 2019 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Jul 16, 2019

Study contacts

Rofaida Raafat, MBBch
Contact
rofaidaraafatchest@gmail.com
01099646399
Maha Elkholy, Professor
Contact
maha_elkholy@yahoo.com
01096956205

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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