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

Completed

• Conditions: Healthy
• Interventions: Device: Recom Model 100; Device: GE 5000 ECG Monitor System

• Registration Number: NCT00998842
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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 Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-03
• Last Update Posted: 2009-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy subjects	Recom Model 100	five male, five female, ages 18-64
healthy subjects	GE 5000 ECG Monitor System	five male, five female, ages 18-64

Primary Outcome Measures

Name	Time	Method
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.	1 year

Trial Locations

Locations (1)

Family Medicine Clinic; 🇺🇸 Tulsa, Oklahoma, United States