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

History of Changes

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


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

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: 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
Study First Received:	October 20, 2009
Last Updated:	November 3, 2009

Keywords provided by University of Oklahoma:


ECG EKG healthy subjects electrocardiography, ambulatory

ClinicalTrials.gov processed this record on July 24, 2017

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