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

NCT ID: NCT02241252

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Cardiac Arrhythmia Qt Interval, Variation in

Keywords

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ECG QT interval Sotalol Dofetilide iPhone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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iPhone ECG QT recording

iPhone ECG

Group Type OTHER

iPhone ECG

Intervention Type DEVICE

Please see detailed description for additional information.

Interventions

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iPhone ECG

Please see detailed description for additional information.

Intervention Type DEVICE

Other Intervention Names

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AliveCor iPhone ECG

Eligibility Criteria

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Inclusion Criteria

* initiation of sotalol or dofetilide
* inpatient at University hospital

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul J Garabelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Dwight W Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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OU_IRB_3237

Identifier Type: -

Identifier Source: org_study_id