Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 9:18 PM
Study NCT ID:
NCT02141269
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
Sponsor:
Scripps Translational Science Institute
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: