NCT00998842

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 4, 2009

Status Verified

October 1, 2009

Enrollment Period

1 month

First QC Date

October 20, 2009

Last Update Submit

November 3, 2009

Conditions

Healthy

Keywords

ECGEKGhealthy subjectselectrocardiography, ambulatory

Outcome Measures

Primary Outcomes (1)

  • ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.

    1 year

Study Arms (1)

healthy subjects

five male, five female, ages 18-64

Device: Recom Model 100Device: GE 5000 ECG Monitor System

Interventions

Recom Model 100DEVICE

Battery Operated, Ambulatory, Digital Wireless ECG Monitor System

healthy subjects
GE 5000 ECG Monitor SystemDEVICE

Wired ECG system

healthy subjects

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals Age 18-64

You may qualify if:

  • Healthy individuals, AND
  • Age 18-64

You may not qualify if:

  • Pregnant women,
  • Prisoners,
  • Have known cardiovascular disease, OR
  • Do not pass the PAR-Q and/or show baseline ECG abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine Clinic

Tulsa, Oklahoma, 74120, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-10

Locations

US(1)