Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

May 19, 2015 updated by: Eric Topol, MD, Scripps Translational Science Institute

Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting

A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).

The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.

Study Overview

Status

Completed

Conditions

Detailed Description

A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.

We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.

This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:

  1. Ejection fraction: estimates how well the heart is squeezing/functioning.
  2. Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
  3. Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
  4. Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
  5. Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
  6. Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
  7. Pericardial effusion: excessive fluid in the sack around the heart.

The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.

A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.

Study Type

Observational

Enrollment (Actual)

200

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
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatient and outpatient subjects with an order for a routine transthoracic echocardiogram based on clinical indications.

Description

Inclusion Criteria:

  1. All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
  2. Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
  3. Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
  4. Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.

Exclusion Criteria:

  1. Subjects who had a limited transthoracic echocardiography (i.e limited views)
  2. Vscan imaging not attempted for a certain parameter

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of HHE and TTE results
Time Frame: 1 time
Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
1 time

Collaborators and Investigators

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

Sponsor

Scripps Translational Science Institute

Investigators

  • Principal Investigator: Eric Topol, MD, Scripps Health

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

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-5906

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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