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

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ClinicalTrials.gov Identifier: NCT02241252
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE September 8, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date May 29, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
Official Title  ICMJE Clinical Validation of an iPhone ECG System, QT Substudy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cardiac Arrhythmia
  • Qt Interval, Variation in
Intervention  ICMJE Device: iPhone ECG
Please see detailed description for additional information.
Other Name: AliveCor iPhone ECG
Study Arms  ICMJE iPhone ECG QT recording
iPhone ECG
Intervention: Device: iPhone ECG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2015)
29
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • initiation of sotalol or dofetilide
  • inpatient at University hospital

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02241252
Other Study ID Numbers  ICMJE OU_IRB_3237
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul J Garabelli, MD University of Oklahoma
Principal Investigator: Dwight W Reynolds, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP