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

Cardiac Arrhythmia Clinical Trial

Official title:

Clinical Validation of an iPhone ECG System, QT Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241252
• Other study ID #: OU_IRB_3237
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: May 28, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• initiation of sotalol or dofetilide

• inpatient at University hospital

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Qt Interval, Variation in

Intervention

Device:
• iPhone ECG
Please see detailed description for additional information.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT interval measurement (in milliseconds)	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.	Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days	No