NCT02241252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

September 8, 2014

Last Update Submit

May 28, 2015

Conditions

Cardiac ArrhythmiaQt Interval, Variation in

Keywords

ECGQT intervalSotalolDofetilideiPhone

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days

Study Arms (1)

iPhone ECG QT recording

OTHER

iPhone ECG

Device: iPhone ECG

Interventions

iPhone ECGDEVICE

Please see detailed description for additional information.

Also known as: AliveCor iPhone ECG
iPhone ECG QT recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • initiation of sotalol or dofetilide
  • inpatient at University hospital

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paul J Garabelli, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Dwight W Reynolds, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 16, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

US(1)