NCT01558518

Brief Summary

Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations. In this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE.

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 Sep 2012

Shorter than P25 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

First Submitted

Initial submission to the registry

March 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

March 17, 2012

Last Update Submit

July 9, 2013

Conditions

Keywords

Handheld echocardiographyV-scanHandheld ultrasoundPortable ultrasound

Eligibility Criteria

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

Patients referred to the Mayo Clinic Echocardiography Laboratory

You may qualify if:

  • Adult patients referred for a resting transthoracic echocardiogram.

You may not qualify if:

  • Referral for quantitative assessment of valvular heart disease
  • Referral for strain imaging
  • Referral for measurement of left atrial mechanical function or cardiac resynchronization studies
  • Known diagnosis of congenital heart disease, restrictive cardiomyopathy, constrictive pericardial disease, or pulmonary hypertension
  • Patients who have received left ventricular assist devices or those who have undergone cardiac transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Cullen MW, Blauwet LA, Vatury OM, Mulvagh SL, Behrenbeck TR, Scott CG, Pellikka PA. Diagnostic capability of comprehensive handheld vs transthoracic echocardiography. Mayo Clin Proc. 2014 Jun;89(6):790-8. doi: 10.1016/j.mayocp.2013.12.016. Epub 2014 Mar 29.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Patricia Pellikka, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Medicine

Study Record Dates

First Submitted

March 17, 2012

First Posted

March 20, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations