Handheld Echocardiography in Clinical Practice

Cardiovascular Disease Clinical Trial

Official title:

Handheld Echocardiography in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558518
• Other study ID #: 11-008019
• Status: Completed
• Phase: N/A
• First received: March 17, 2012
• Last updated: July 9, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,