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

December 15, 2016 updated by: Yale University

The Inter-observer Reliability and Diagnostic Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected Pulmonary Embolus in the Emergency Department

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Chris Moore, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1412015010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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