Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT02141269
• Lead Sponsor: Scripps Translational Science Institute

Brief Summary

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-19
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of HHE and TTE results	1 time	Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States