- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05161065
Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG
Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG in Subjects Hospitalized for Antiarrhythmic Drug Initiation and Follow-up
Study Overview
Detailed Description
The WatchQT Study is a prospective, non-significant risk, non-randomized, monocentric, open, comparative, concordance pilot study.
Under subject consent, subjects hospitalized for AAD initiation and monitoring will have smartwatch ECG recordings done simultaneously with 12-lead ECG measurements before and after drug administration twice a day, in accordance with the existing in-stay subject monitoring protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects over 22, able and willing to participate in the study
- Subjects who are admitted to the hospital in NSR or AF and are eligible for AAD (class Ia or class III) dose initiation or re-initiation.
- Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
Exclusion Criteria:
- Subjects with Cardiac Implantable Electronic Devices (CIED)
- Pregnant or breast-feeding subjects
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Concordance between QTc intervals measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG for each measurement done during NSR.
The Bazett (QTcB in ms) and Fridericia (QTcF in ms) methods will be used to correct QT intervals
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
|
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI in determining subjects at risk of AAD induced ventricular arrhythmia compared to that identified by manually read 12-lead ECG in subjects with a prolonged QTc > 500 ms and/or subjects with a QTc prolongation of > 15% after their initial AAD dose
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Concordance between QTcB and QTcF intervals measured by the different methods
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Concordance between QTcB and QTcF intervals measured by the different methods (smartwatch combined with Cardiologs AI, smartwatch read manually, 12-lead read manually, lead 1 from 12-lead read manually and automated interpretation of the 12 lead ECG machine)
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Description of the QTc interval measurements in NSR
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Description of the QTc interval measurements in NSR as a function of timepoints by the different methods
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Quantitative analysis to determine the interobserver variability
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Quantitative analysis to determine the interobserver variability in QTc interval measurements by the smartwatch and 12-lead ECG manual readings
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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.Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG at each timepoint and overall.
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Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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Analysis of QT interval measured in subsets of subjects with and without wide QRS
Time Frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
|
Patient with wide QRS is determined as a QRS>120ms at D0 from automated interpretation of the 12-lead ECG machine.
The analysis will be done in subset of 2 groups according to the QRS measured as wide or not machine
|
Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jagmeet Singh, MD ScM DPhil, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WatchQT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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