Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

Status Completed

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02141269
Study type	Observational
Source	Scripps Translational Science Institute
Contact
Status	Completed
Phase	N/A
Start date	June 2012
Completion date	May 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.