NCT04020250

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 9, 2019

Last Update Submit

July 11, 2019

Conditions

Outcome Measures

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.

    one month

Interventions

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with pulmonary embolism confirmed by contrast-enhanced multidetector computed tomography (MDCT) when thrombo-emboli were visualized

You may qualify if:

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

You may not qualify if:

  • Age \<18 years.
  • Patients diagnosed with chronic thromboembolic hypertension.
  • Patients with valvular heart diseases.
  • Patients with lung cancer.
  • Acute massive pulmonary embolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31272591BACKGROUND
  • 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.

    PMID: 31264657BACKGROUND
  • 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.

    PMID: 31184782BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Rofaida Raafat, MBBch

CONTACT

Maha Elkholy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 16, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

July 16, 2019

Record last verified: 2019-07