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Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998842
First Posted: October 21, 2009
Last Update Posted: November 4, 2009
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.
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma
  Purpose
To determine if there is a difference between wireless ECG and wired ECG findings.

Condition Intervention
Healthy Device: Recom Model 100 Device: GE 5000 ECG Monitor System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • ECG recordings from the wireless system will be equivalent to recordings from the standard wired system. [ Time Frame: 1 year ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy subjects
five male, five female, ages 18-64
Device: Recom Model 100
Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
Device: GE 5000 ECG Monitor System
Wired ECG system

Detailed Description:
The aim of the study is to compare ECG recordings from the Signalife Fidelity 100 Wireless 12-lead ECG Monitor System to that of the GE 5000 Wired 12-lead ECG Monitor System during rest and while walking. We hypothesize that ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals Age 18-64
Criteria

Inclusion Criteria:

  • Healthy individuals, AND
  • Age 18-64

Exclusion Criteria:

  • Pregnant women,
  • Prisoners,
  • Have known cardiovascular disease, OR
  • Do not pass the PAR-Q and/or show baseline ECG abnormalities.
  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): NCT00998842


Locations
United States, Oklahoma
Family Medicine Clinic
Tulsa, Oklahoma, United States, 74120
Sponsors and Collaborators
University of Oklahoma
Oklahoma State University Center for Health Sciences
  More Information

Responsible Party: Thomas Allen, DO, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00998842     History of Changes
Other Study ID Numbers: OU IRB 14853
First Submitted: October 20, 2009
First Posted: October 21, 2009
Last Update Posted: November 4, 2009
Last Verified: October 2009

Keywords provided by University of Oklahoma:
ECG
EKG
healthy subjects
electrocardiography, ambulatory