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Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED

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ClinicalTrials.gov Identifier: NCT02356120
Recruitment Status : Withdrawn
First Posted : February 5, 2015
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)

Condition or disease Intervention/treatment
Pulmonary Embolism Other: Echocardiogram

Detailed Description:
This will be a prospective observational cohort study aimed at determining the utility and reproducibility of TAPSE, in patients who present to the emergency department with suspected pulmonary embolism (PE). The gold standard diagnostic test for PE is computed tomography of the pulmonary arteries (CTPA). Any patient for whom a CTPA is ordered because of suspected PE is eligible for study inclusion

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Inter-observer Reliability and Diagnostic Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected Pulmonary Embolus in the Emergency Department
Study Start Date : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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Group/Cohort Intervention/treatment
Suspected Pulmonary Embolus
Patients with suspected pulmonary embolus who are getting a CTPA
Other: Echocardiogram
Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram




Primary Outcome Measures :
  1. Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis) [ Time Frame: 0 days ]
    The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis


Secondary Outcome Measures :
  1. Inter-Observer Agreement (To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.) [ Time Frame: 0 days ]
    To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population will consist of a convenience sample, taken when study investigators are available, of all those patients for whom suspicion of PE is high enough that their attending physician has ordered a CTPA in the ED
Criteria

Inclusion Criteria:

  • Concern for PE by attending physician and CTPA ordered

Exclusion Criteria:

  • If patient is under the age of 18, a prisoner, or a ward of the state
  • CTPA ordered but not performed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356120


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Chris Moore, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02356120     History of Changes
Other Study ID Numbers: 1412015010
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases