Expired Study
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New Haven, Connecticut 06519


Purpose:

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 summary:

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


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


Study is Available At:


Original ID:

1412015010


NCT ID:

NCT02356120


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Chris Moore, MD
Principal Investigator
Yale University

Study Dates

Start Date:February 2015
Completion Date:November 2016
Completion Type:Actual
Primary Completion Date:November 2016
Primary Completion Type:Actual
Verification Date:December 2016
Last Changed Date:December 15, 2016
First Received Date:January 30, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.
Outcome Type:Primary Outcome
Measure:Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis)
Time Frame:0 days
Safety Issues:False
Description:The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis

Study Interventions

Intervention Type:Other
Name:Echocardiogram
Description:Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram
Arm Name:Suspected Pulmonary Embolus

Study Arms

Study Arm Type:Other
Arm Name:Suspected Pulmonary Embolus
Description:Patients with suspected pulmonary embolus who are getting a CTPA

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University

Samples and Retentions

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
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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