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

This study has been completed.
Sponsor:
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00998842
First received: October 20, 2009
Last updated: November 3, 2009
Last verified: October 2009

October 20, 2009
November 3, 2009
October 2009
November 2009   (final data collection date for primary outcome measure)
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998842 on ClinicalTrials.gov Archive Site
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Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG
Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Healthy individuals Age 18-64

Healthy
  • Device: Recom Model 100
    Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
  • Device: GE 5000 ECG Monitor System
    Wired ECG system
healthy subjects
five male, five female, ages 18-64
Interventions:
  • Device: Recom Model 100
  • Device: GE 5000 ECG Monitor System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998842
OU IRB 14853
Not Provided
Thomas Allen, DO, University of Oklahoma
University of Oklahoma
Oklahoma State University Center for Health Sciences
Not Provided
University of Oklahoma
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP