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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Qt Interval, Variation in Device: iPhone ECG Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Validation of an iPhone ECG System, QT Substudy
Study Start Date : September 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
iPhone ECG QT recording
iPhone ECG
 Device: iPhone ECG
Please see detailed description for additional information.
Other Name: AliveCor iPhone ECG


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • initiation of sotalol or dofetilide
  • inpatient at University hospital

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241252


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Paul J Garabelli, MD University of Oklahoma
Principal Investigator: Dwight W Reynolds, MD University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02241252    
Other Study ID Numbers: OU_IRB_3237
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by University of Oklahoma:
ECG
QT interval
Sotalol
Dofetilide
iPhone
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes