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Handheld Echocardiography in Clinical Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558518
First Posted: March 20, 2012
Last Update Posted: January 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia A. Pellikka, Mayo Clinic
  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 Patricia A. Pellikka, Mayo Clinic:

Enrollment: 200
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558518


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Patricia Pellikka, MD Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia A. Pellikka, MD, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01558518     History of Changes
Other Study ID Numbers: 11-008019
First Submitted: March 17, 2012
First Posted: March 20, 2012
Last Update Posted: January 23, 2015
Last Verified: July 2013

Keywords provided by Patricia A. Pellikka, Mayo Clinic:
Handheld echocardiography
V-scan
Handheld ultrasound
Portable ultrasound

Additional relevant MeSH terms:
Cardiovascular Diseases