• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

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.

DOI:10.1016/j.jelectrocard.2017.08.025
PMID:29021091
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5699480/
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。

相似文献

1
An evaluation of multiple algorithms for the measurement of the heart rate corrected JTpeak interval.心率校正JTpeak间期测量的多种算法评估
J Electrocardiol. 2017 Nov-Dec;50(6):769-775. doi: 10.1016/j.jelectrocard.2017.08.025. Epub 2017 Sep 1.
2
Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA.用于在CiPA下确认药物电生理效应以进行致心律失常风险预测的心电图生物标志物。
J Electrocardiol. 2017 Nov-Dec;50(6):808-813. doi: 10.1016/j.jelectrocard.2017.08.003. Epub 2017 Aug 9.
3
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.
4
Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil.多非利特、奎尼丁、雷诺嗪和维拉帕米随机临床研究中的全面T波形态评估
J Am Heart Assoc. 2015 Apr 13;4(4):e001615. doi: 10.1161/JAHA.114.001615.
5
The J to T-peak interval as a biomarker in drug safety studies: A method of accuracy assessment applied to two algorithms.J 波至 T 波峰间期作为药物安全性研究中的生物标志物:一种应用于两种算法的准确性评估方法。
J Electrocardiol. 2017 Nov-Dec;50(6):758-761. doi: 10.1016/j.jelectrocard.2017.07.011. Epub 2017 Jul 12.
6
Assessment of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) as proarrhythmia biomarkers in non-human primates: Outcome from a HESI consortium.评估非人类灵长类动物校正的 JT 峰值(JTpc)和 TpTec(TpTec)作为致心律失常生物标志物:HESI 联盟的研究结果。
J Pharmacol Toxicol Methods. 2024 Sep-Oct;129:107543. doi: 10.1016/j.vascn.2024.107543. Epub 2024 Jul 15.
7
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
Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block.用于检测药物诱导的晚期钠电流阻滞的心电图生物标志物
PLoS One. 2016 Dec 30;11(12):e0163619. doi: 10.1371/journal.pone.0163619. eCollection 2016.
9
A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium.JTPc 和 Tp-Tec 作为临床前物种致心律失常生物标志物的概念验证评估:HESI 赞助联盟的回顾性分析。
Int J Toxicol. 2019 Jan/Feb;38(1):23-32. doi: 10.1177/1091581818813601. Epub 2018 Dec 19.
10
Evaluation of the Effect of 5 QT-Positive Drugs on the JTpeak Interval - An Analysis of ECGs From the IQ-CSRC Study.评价 5 种 QT 阳性药物对 JTpeak 间期的影响——来自 IQ-CSRC 研究的心电图分析。
J Clin Pharmacol. 2020 Jan;60(1):125-139. doi: 10.1002/jcph.1502. Epub 2019 Aug 5.

引用本文的文献

1
Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates).用于减少临床试验并改善 QTc 和致心律失常风险的监管决策的转化模型和工具(ICH E14/S7B 更新)。
Clin Pharmacol Ther. 2021 Feb;109(2):319-333. doi: 10.1002/cpt.2137. Epub 2021 Jan 7.
2
QT Assessment in Early Drug Development: The Long and the Short of It.早期药物研发中的 QT 评估:长与短。
Int J Mol Sci. 2019 Mar 15;20(6):1324. doi: 10.3390/ijms20061324.
3
Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.

本文引用的文献

1
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
基于机制模型的药物致心律失常风险评估:“CiPA”计划综述及前瞻性临床验证研究设计
Clin Pharmacol Ther. 2018 Jan;103(1):54-66. doi: 10.1002/cpt.896. Epub 2017 Nov 16.
J Electrocardiol. 2017 Nov-Dec;50(6):752-757. doi: 10.1016/j.jelectrocard.2017.07.010. Epub 2017 Jul 14.
4
The J to T-peak interval as a biomarker in drug safety studies: A method of accuracy assessment applied to two algorithms.J 波至 T 波峰间期作为药物安全性研究中的生物标志物:一种应用于两种算法的准确性评估方法。
J Electrocardiol. 2017 Nov-Dec;50(6):758-761. doi: 10.1016/j.jelectrocard.2017.07.011. Epub 2017 Jul 12.
5
Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block.用于检测药物诱导的晚期钠电流阻滞的心电图生物标志物
PLoS One. 2016 Dec 30;11(12):e0163619. doi: 10.1371/journal.pone.0163619. eCollection 2016.
6
Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk.用于评估药物诱导的心律失常风险的J峰和T峰-终末间期的自动算法
PLoS One. 2016 Dec 30;11(12):e0166925. doi: 10.1371/journal.pone.0166925. eCollection 2016.
7
Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias.用于评估药物诱导心律失常的人诱导多能干细胞衍生心肌细胞的综合转化评估
Toxicol Sci. 2017 Jan;155(1):234-247. doi: 10.1093/toxsci/kfw200. Epub 2016 Oct 3.
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.
10
Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.药物诱导的长QT综合征的晚钠电流阻滞:一项前瞻性临床试验的结果。
Clin Pharmacol Ther. 2016 Feb;99(2):214-23. doi: 10.1002/cpt.205. Epub 2015 Nov 28.