Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG
This study has been completed.
Sponsor:
University of Oklahoma
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
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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 ] [ Designated as safety issue: No ]
| 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) |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00998842
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 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
ECG EKG healthy subjects electrocardiography, ambulatory |
ClinicalTrials.gov processed this record on September 27, 2016