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心率校正JTpeak间期测量的多种算法评估

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

作者信息

Couderc Jean-Philippe, Ma Shiyang, Page Alex, Besaw Connor, Xia Jean, Chiu W Brian, de Bie Johan, Vicente Jose, Vaglio Martino, Badilini Fabio, Babaeizadeh Saeed, Chien Cheng-Hao Simon, Baumert Mathias

机构信息

Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.

Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY 14618, USA.

出版信息

J Electrocardiol. 2017 Nov-Dec;50(6):769-775. doi: 10.1016/j.jelectrocard.2017.08.025. Epub 2017 Sep 1.

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.

摘要

对药物对体表心电图心率校正JT波峰(JTpc)间期影响的关注,在监管科学领域引发了越来越多的科学研究,尤其是在体外全面致心律失常试验(CiPA)倡议的背景下。我们开展了一项新举措,通过比较自动JTpc测量技术区分多通道和单通道阻断药物的能力,来评估其作用。美国食品药品监督管理局(通过遥测和动态心电图数据库)与3家心电图设备公司(AMPS、莫塔拉和飞利浦)共享了一组5232份心电图。我们评估了商业技术和美国食品药品监督管理局技术在这些测量中药物浓度效应的差异。我们描述了多非利特、奎尼丁、雷诺嗪和维拉帕米从基线起药物诱导的安慰剂校正变化,并讨论了所有技术之间的各种差异。结果显示,本研究评估的测量技术之间只有微小差异。这也证实,在该数据集中,在评估多非利特、奎尼丁、雷诺嗪和维拉帕米的效应时,JTpc间期能够区分多通道和单通道(hERG)阻断药物。然而,在奎尼丁和多非利特的情况下,由于T波形态异常时T波峰(T顶点)位置缺乏标准定义,我们注意到各技术之间的一致性较差。

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本文引用的文献

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The algorithmic performance of J-Tpeak for drug safety clinical trial.用于药物安全性临床试验的J-Tpeak算法性能。
J Electrocardiol. 2017 Nov-Dec;50(6):762-768. doi: 10.1016/j.jelectrocard.2017.08.018. Epub 2017 Aug 15.
2
JT interval: What does this interval mean?JT间期:这个间期是什么意思?
J Electrocardiol. 2017 Nov-Dec;50(6):748-751. doi: 10.1016/j.jelectrocard.2017.07.019. Epub 2017 Aug 3.
3
Automated JTpeak analysis by BRAVO.BRAVO自动J T波峰分析
J Electrocardiol. 2017 Nov-Dec;50(6):752-757. doi: 10.1016/j.jelectrocard.2017.07.010. Epub 2017 Jul 14.
8
Evolving regulatory paradigm for proarrhythmic risk assessment for new drugs.新药致心律失常风险评估的不断演变的监管范式
J Electrocardiol. 2016 Nov-Dec;49(6):837-842. doi: 10.1016/j.jelectrocard.2016.07.017. Epub 2016 Jul 28.
9
The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative - Update on progress.体外全面致心律失常试验(CiPA)计划——进展更新
J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:15-20. doi: 10.1016/j.vascn.2016.06.002. Epub 2016 Jun 7.

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