Back to resultsUsing an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Primary Purpose
Cardiac Arrhythmia, Qt Interval, Variation in
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPhone ECG
Sponsored by
About this trial
This is an interventional screening trial for Cardiac Arrhythmia focused on measuring ECG, QT interval, Sotalol, Dofetilide, iPhone
Eligibility Criteria
Inclusion Criteria:
- initiation of sotalol or dofetilide
- inpatient at University hospital
Exclusion Criteria:
- none
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
iPhone ECG QT recording
Arm Description
iPhone ECG
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02241252
Brief Title
Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Official Title
Clinical Validation of an iPhone ECG System, QT Substudy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia, Qt Interval, Variation in
Keywords
ECG, QT interval, Sotalol, Dofetilide, iPhone
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iPhone ECG QT recording
Arm Type
Other
Arm Description
iPhone ECG
Intervention Type
Device
Intervention Name(s)
iPhone ECG
Other Intervention Name(s)
AliveCor iPhone ECG
Intervention Description
Please see detailed description for additional information.
Primary Outcome Measure Information:
Title
QT interval measurement (in milliseconds)
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
initiation of sotalol or dofetilide
inpatient at University hospital
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Garabelli, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dwight W Reynolds, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
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Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
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