Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141269
• Other study ID #: 12-5906
• Status: Completed
• Phase: N/A
• First received: June 28, 2012
• Last updated: May 19, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
United States	Scripps Green Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of HHE and TTE results	Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.	1 time	No