Handheld Echocardiography in Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia A. Pellikka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01558518
First received: March 17, 2012
Last updated: July 9, 2013
Last verified: July 2013
  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:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Mayo Clinic

Additional 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
Study First Received: March 17, 2012
Last Updated: July 9, 2013
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 August 28, 2014