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

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ClinicalTrials.gov Identifier: NCT00998842
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : November 4, 2009
Sponsor:
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma

Brief Summary:
To determine if there is a difference between wireless ECG and wired ECG findings.

Condition or disease Intervention/treatment
Healthy Device: Recom Model 100 Device: GE 5000 ECG Monitor 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.

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Group/Cohort Intervention/treatment
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



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


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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.

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

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

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