Literature DB >> 29021091

An evaluation of multiple algorithms for the measurement of the heart rate corrected JTpeak interval.

Jean-Philippe Couderc1, Shiyang Ma2, Alex Page3, Connor Besaw3, Jean Xia3, W Brian Chiu4, Johan de Bie4, Jose Vicente5, Martino Vaglio6, Fabio Badilini6, Saeed Babaeizadeh7, Cheng-Hao Simon Chien7, Mathias Baumert8.   

Abstract

Interest in the effects of drugs on the heart rate-corrected JTpeak (JTpc) interval from the body-surface ECG has spawned an increasing number of scientific investigations in the field of regulatory sciences, and more specifically in the context of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. We conducted a novel initiative to evaluate the role of automatic JTpc measurement technologies by comparing their ability to distinguish multi- from single-channel blocking drugs. A set of 5232 ECGs was shared by the FDA (through the Telemetric and Holter ECG Warehouse) with 3 ECG device companies (AMPS, Mortara, and Philips). We evaluated the differences in drug-concentration effects on these measurements between the commercial and the FDA technologies. We provide a description of the drug-induced placebo-corrected changes from baseline for dofetilide, quinidine, ranolazine, and verapamil, and discuss the various differences across all technologies. The results revealed only small differences between measurement technologies evaluated in this study. It also confirms that, in this dataset, the JTpc interval distinguishes between multi- and single-channel (hERG) blocking drugs when evaluating the effects of dofetilide, quinidine, ranolazine, and verapamil. However, in the case of quinidine and dofetilide, we noticed a poor consistency across technologies because of the lack of standard definitions for the location of the peak of the T-wave (T-apex) when the T-wave morphology is abnormal.
Copyright © 2017 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Cardiac safety; CiPA; Electrocardiogram; Long QT syndrome; QT; Torsade de pointes

Mesh:

Substances:

Year:  2017        PMID: 29021091      PMCID: PMC5699480          DOI: 10.1016/j.jelectrocard.2017.08.025

Source DB:  PubMed          Journal:  J Electrocardiol        ISSN: 0022-0736            Impact factor:   1.438


  18 in total

1.  The telemetric and Holter ECG warehouse initiative (THEW): a data repository for the design, implementation and validation of ECG-related technologies.

Authors:  Jean-Philippe Couderc
Journal:  Annu Int Conf IEEE Eng Med Biol Soc       Date:  2010

2.  The J to T-peak interval as a biomarker in drug safety studies: A method of accuracy assessment applied to two algorithms.

Authors:  W Brian Chiu; Johan de Bie; David W Mortara
Journal:  J Electrocardiol       Date:  2017-07-12       Impact factor: 1.438

3.  Transformation of the Mason-Likar 12-lead electrocardiogram to the Frank vectorcardiogram.

Authors:  Daniel Guldenring; Dewar D Finlay; David G Strauss; Loriano Galeotti; Chris D Nugent; Mark P Donnelly; Raymond R Bond
Journal:  Conf Proc IEEE Eng Med Biol Soc       Date:  2012

4.  The algorithmic performance of J-Tpeak for drug safety clinical trial.

Authors:  Simon C Chien; Richard E Gregg
Journal:  J Electrocardiol       Date:  2017-08-15       Impact factor: 1.438

5.  The Telemetric and Holter ECG Warehouse (THEW): the first three years of development and research.

Authors:  Jean-Philippe Couderc
Journal:  J Electrocardiol       Date:  2012-09-28       Impact factor: 1.438

6.  JT interval: What does this interval mean?

Authors:  Wojciech Zareba; Scott McNitt; Slava Polonsky; Jean-Philippe Couderc
Journal:  J Electrocardiol       Date:  2017-08-03       Impact factor: 1.438

7.  Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias.

Authors:  Ksenia Blinova; Jayna Stohlman; Jose Vicente; Dulciana Chan; Lars Johannesen; Maria P Hortigon-Vinagre; Victor Zamora; Godfrey Smith; William J Crumb; Li Pang; Beverly Lyn-Cook; James Ross; Mathew Brock; Stacie Chvatal; Daniel Millard; Loriano Galeotti; Norman Stockbridge; David G Strauss
Journal:  Toxicol Sci       Date:  2016-10-03       Impact factor: 4.849

8.  Comparison of automated measurements of electrocardiographic intervals and durations by computer-based algorithms of digital electrocardiographs.

Authors:  Paul Kligfield; Fabio Badilini; Ian Rowlandson; Joel Xue; Elaine Clark; Brian Devine; Peter Macfarlane; Johan de Bie; David Mortara; Saeed Babaeizadeh; Richard Gregg; Eric D Helfenbein; Cynthia L Green
Journal:  Am Heart J       Date:  2013-10-17       Impact factor: 4.749

9.  Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk.

Authors:  Lars Johannesen; Jose Vicente; Meisam Hosseini; David G Strauss
Journal:  PLoS One       Date:  2016-12-30       Impact factor: 3.240

10.  Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block.

Authors:  Jose Vicente; Lars Johannesen; Meisam Hosseini; Jay W Mason; Philip T Sager; Esther Pueyo; David G Strauss
Journal:  PLoS One       Date:  2016-12-30       Impact factor: 3.240

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  2 in total

Review 1.  Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates).

Authors:  David G Strauss; Wendy W Wu; Zhihua Li; John Koerner; Christine Garnett
Journal:  Clin Pharmacol Ther       Date:  2021-01-07       Impact factor: 6.875

Review 2.  Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.

Authors:  Jose Vicente; Robbert Zusterzeel; Lars Johannesen; Jay Mason; Philip Sager; Vikram Patel; Murali K Matta; Zhihua Li; Jiang Liu; Christine Garnett; Norman Stockbridge; Issam Zineh; David G Strauss
Journal:  Clin Pharmacol Ther       Date:  2017-11-16       Impact factor: 6.875

  2 in total

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