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An evaluation of multiple algorithms for the measurement of the heart rate corrected JTpeak interval.
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.
Afiliação
  • Couderc JP; Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA. Electronic address: heartjpc@heart.rochester.edu.
  • Ma S; Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY 14618, USA.
  • Page A; Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
  • Besaw C; Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
  • Xia J; Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
  • Chiu WB; Mortara Instrument Europe s.r.l., Via Cimarosa 103, 40033 Casalecchio di Reno, BO, Italy.
  • de Bie J; Mortara Instrument Europe s.r.l., Via Cimarosa 103, 40033 Casalecchio di Reno, BO, Italy.
  • Vicente J; Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA.
  • Vaglio M; AMPS LLC, 418 Central Park W, Suite 21C, 10025 New York, NY, USA.
  • Badilini F; AMPS LLC, 418 Central Park W, Suite 21C, 10025 New York, NY, USA.
  • Babaeizadeh S; Advanced Algorithm Research Center, Philips Healthcare, Andover, MA, USA.
  • Chien CS; Advanced Algorithm Research Center, Philips Healthcare, Andover, MA, USA.
  • Baumert M; School of Electrical and Electronic Engineering, The University of Adelaide, SA 5005, Australia.
J Electrocardiol ; 50(6): 769-775, 2017.
Article em En | MEDLINE | ID: mdl-29021091
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Algoritmos / Síndrome do QT Longo / Biomarcadores / Torsades de Pointes / Eletrocardiografia Ambulatorial / Bloqueadores dos Canais de Potássio / Bloqueadores dos Canais de Sódio / Sistema de Condução Cardíaco / Canais Iônicos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Humans Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Algoritmos / Síndrome do QT Longo / Biomarcadores / Torsades de Pointes / Eletrocardiografia Ambulatorial / Bloqueadores dos Canais de Potássio / Bloqueadores dos Canais de Sódio / Sistema de Condução Cardíaco / Canais Iônicos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Humans Idioma: En Ano de publicação: 2017 Tipo de documento: Article