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Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

Primary Purpose

Pulmonary Embolism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
speckle tracking echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. clinical diagnosis of acute pulmonary embolism
  2. Age: 20 - 70 years.

Exclusion Criteria:

  1. coronary artery disease
  2. patient of Atrial fibrillation.
  3. Patient of impaired RV function due to chest disease (Cor-pulmonale)
  4. patient with impaired Ejection fraction (EF) <50%
  5. Moderate to severe valvular heart disease.
  6. Atrio-ventricular conduction disturbance.
  7. Poor echogenicity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patients with acute pulmonary embolism

    Arm Description

    speckle tracking echocardiography for patient with acute pulmonary embolism

    Outcomes

    Primary Outcome Measures

    improve management of acute pulmonary embolism
    comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism

    Secondary Outcome Measures

    Full Information

    First Posted
    October 26, 2020
    Last Updated
    November 1, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04609605
    Brief Title
    Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
    Official Title
    Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography To evaluate its relationship to long term mortality.
    Detailed Description
    Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate > 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Embolism

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with acute pulmonary embolism
    Arm Type
    Experimental
    Arm Description
    speckle tracking echocardiography for patient with acute pulmonary embolism
    Intervention Type
    Device
    Intervention Name(s)
    speckle tracking echocardiography
    Intervention Description
    speckle tracking echocardiography of right ventricle
    Primary Outcome Measure Information:
    Title
    improve management of acute pulmonary embolism
    Description
    comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of acute pulmonary embolism Age: 20 - 70 years. Exclusion Criteria: coronary artery disease patient of Atrial fibrillation. Patient of impaired RV function due to chest disease (Cor-pulmonale) patient with impaired Ejection fraction (EF) <50% Moderate to severe valvular heart disease. Atrio-ventricular conduction disturbance. Poor echogenicity
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Said rashwan, master degree of cardiology
    Phone
    01007949203
    Email
    dr.ma7moudsaid@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27126645
    Citation
    Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
    Results Reference
    background
    PubMed Identifier
    8752195
    Citation
    McConnell MV, Solomon SD, Rayan ME, Come PC, Goldhaber SZ, Lee RT. Regional right ventricular dysfunction detected by echocardiography in acute pulmonary embolism. Am J Cardiol. 1996 Aug 15;78(4):469-73. doi: 10.1016/s0002-9149(96)00339-6.
    Results Reference
    background
    PubMed Identifier
    28495379
    Citation
    Fields JM, Davis J, Girson L, Au A, Potts J, Morgan CJ, Vetter I, Riesenberg LA. Transthoracic Echocardiography for Diagnosing Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jul;30(7):714-723.e4. doi: 10.1016/j.echo.2017.03.004. Epub 2017 May 9.
    Results Reference
    background
    PubMed Identifier
    31064715
    Citation
    Trivedi SJ, Altman M, Stanton T, Thomas L. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9):1320-1330. doi: 10.1016/j.hlc.2019.03.012. Epub 2019 Apr 12.
    Results Reference
    background

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    Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

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