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Clinical Trials/NCT02241252
NCT02241252
Completed
Not Applicable

Clinical Validation of an iPhone ECG System, QT Substudy

University of Oklahoma1 site in 1 country29 target enrollmentSeptember 1, 2013

Overview

Phase
Not Applicable
Intervention
iPhone ECG
Conditions
Cardiac Arrhythmia
Sponsor
University of Oklahoma
Enrollment
29
Locations
1
Primary Endpoint
QT interval measurement (in milliseconds)
Status
Completed
Last Updated
25 days ago

Overview

Brief Summary

This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.

Detailed Description

Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III. These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.

Registry
clinicaltrials.gov
Start Date
September 1, 2013
End Date
May 1, 2015
Last Updated
25 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • initiation of sotalol or dofetilide
  • inpatient at University hospital

Exclusion Criteria

  • Not provided

Arms & Interventions

iPhone ECG QT recording

iPhone ECG

Intervention: iPhone ECG

Outcomes

Primary Outcomes

QT interval measurement (in milliseconds)

Time Frame: Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days

The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.

Study Sites (1)

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