AI Article Synopsis

  • The study investigates the impact of various drugs on the heart's JTpeak (JTpc) interval using ECG technology, as part of the CiPA initiative aimed at improving drug safety assessment.
  • Researchers compared the performance of three ECG device companies (AMPS, Mortara, and Philips) against FDA technologies, using a dataset of 5,232 ECGs provided by the FDA.
  • The findings indicate that while the JTpc interval can effectively differentiate multi-channel from single-channel blocking drugs, inconsistencies arose in measuring drugs like quinidine and dofetilide due to varying definitions of T-wave peak locations when T-wave shapes are irregular.

Article 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5699480PMC
http://dx.doi.org/10.1016/j.jelectrocard.2017.08.025DOI Listing

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