Handheld Echocardiography in Clinical Practice

NCT ID: NCT01558518

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Patricia A. Pellikka

MD, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Pellikka, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24684783 (View on PubMed)

Other Identifiers

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11-008019

Identifier Type: -

Identifier Source: org_study_id

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