Handheld Echocardiography in Clinical Practice

This study is currently recruiting participants.

Verified November 2012 by Mayo Clinic

Sponsor:

Information provided by (Responsible Party):

Patricia A. Pellikka, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01558518

First received: March 17, 2012

Last updated: November 7, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition
Cardiovascular Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Handheld Echocardiography in Clinical Practice

Further study details as provided by Mayo Clinic:

Estimated Enrollment:	200
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients referred to the Mayo Clinic Echocardiography Laboratory

Criteria

Inclusion criteria

Adult patients referred for a resting transthoracic echocardiogram.

Exclusion criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558518

Locations

United States, Minnesota
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pellikka, MD pellikka.patricia@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Patricia Pellikka, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Patricia A. Pellikka, MD, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01558518 History of Changes
Other Study ID Numbers:	11-008019
Study First Received:	March 17, 2012
Last Updated:	November 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Handheld echocardiography
V-scan
Handheld ultrasound
Portable ultrasound

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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