Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02241252|
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrhythmia Qt Interval, Variation in||Device: iPhone ECG||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
iPhone ECG QT recording
Device: iPhone ECG
Please see detailed description for additional information.
Other Name: AliveCor iPhone ECG
- 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.
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
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Paul J Garabelli, MD||University of Oklahoma|
|Principal Investigator:||Dwight W Reynolds, MD||University of Oklahoma|