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OpenTrials
Completed

NCT Number: NCT02141269

Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Green Hospital

La Jolla, California, 92037, United States

About this study

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:

  • Ejection fraction: estimates how well the heart is squeezing/functioning.
  • 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.
  • Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
  • Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
  • Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
  • Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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