Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG
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| ClinicalTrials.gov Identifier: NCT00998842 |
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Recruitment Status
:
Completed
First Posted
: October 21, 2009
Last Update Posted
: November 4, 2009
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Sponsor:
University of Oklahoma
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma
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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 |
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 |
|---|---|
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healthy subjects
five male, five female, ages 18-64
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Device: Recom Model 100
Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
Device: GE 5000 ECG Monitor System
Wired ECG system
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Primary Outcome Measures
:
- ECG recordings from the wireless system will be equivalent to recordings from the standard wired system. [ Time Frame: 1 year ]
Information from the National Library of Medicine
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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:
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ECG EKG healthy subjects electrocardiography, ambulatory |