NCT02141269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

June 28, 2012

Last Update Submit

May 19, 2015

Conditions

Cardiac Disease

Keywords

Transthoracic echocardiogramHand-held Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Comparison of HHE and TTE results

    Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.

    1 time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient and outpatient subjects with an order for a routine transthoracic echocardiogram based on clinical indications.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Eric Topol, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2012

First Posted

May 19, 2014

Study Start

June 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

US(1)