NCT02356120

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)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

January 30, 2015

Last Update Submit

December 15, 2016

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis)

    The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis

    0 days

Secondary Outcomes (1)

  • Inter-Observer Agreement (To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.)

    0 days

Study Arms (1)

Suspected Pulmonary Embolus

Patients with suspected pulmonary embolus who are getting a CTPA

Other: Echocardiogram

Interventions

EchocardiogramOTHER

Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram

Suspected Pulmonary Embolus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Concern for PE by attending physician and CTPA ordered

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Chris Moore, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 5, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

US(1)