Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients

Not Applicable

Completed

• Conditions: Qt Interval, Variation in; Cardiac Arrhythmia
• Interventions: Device: iPhone ECG

• Registration Number: NCT02241252
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• initiation of sotalol or dofetilide
• inpatient at University hospital

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iPhone ECG QT recording	iPhone ECG	iPhone ECG

Primary Outcome Measures

Name	Time	Method
QT interval measurement (in milliseconds)	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.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States