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ABSTRACT: In this study, we investigated the ability of a QT algorithm to detect small drug-induced QT interval prolongation by adopting a ldquohighly-automatizedrdquo approach. In a set of 8,911 digital ECGs, we analyzed the drug-concentration profile of computerized QTc to the measurements submitted to the Food and Drug Administration (FDA) by pharmaceutical companies. The RR and QT intervals were measured using lead II based on a QT algorithm included in the COMPAS software package developed at University of Rochester Medical Center, NY. When comparing the time-dependent effect of the drug on the QTc interval the automatic technique produced results similar to the measurements reported by contract research organizations to the Agency (FDA).
Computers in Cardiology, 2008; 10/2008
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ABSTRACT: Assessing the propensity of an individual to drug-induced arrhythmias when exposed to a QT-prolonging drug is challenging because baseline QT prolongation has limited predictive value. In this study, we investigated the role of computerized ECG parameters quantifying T-wave morphology for the identification of individuals who developed drug-induced torsades de pointes (TdPs). In 34 patients, 5-minute digital ECGs have been acquired at baseline and during sotalol challenge. Seventeen of these patients had a history of drug-induced TdPs. We identified specific baseline features of the T-waves common to patients with history of TdPs. The sotalol-induced changes of T-wave morphologies were also different between the two groups suggesting that ECGs may provide relevant information for the identification of patients with an increased propensity to TdPs.
Computers in Cardiology, 2007; 11/2007
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ABSTRACT: We developed a new technique for the measurements of repolarization abnormalities from surface ECGs; this method improves sensitivity and specificity of the current technique used to identify the presence of a drug called moxifloxacin. This drug is used as a positive control compound in clinical studies investigating the level of drug cardiotoxicity related to the ventricular repolarization process. We describe a new technology and the preliminary results revealing the superiority of our technique in comparison to QT interval prolongation. This technology may play an important role in the future of drug-safety assessment.
Computers in Cardiology, 2006; 10/2006
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ABSTRACT: Several important non-cardiac drugs have been removed from the market after revealing harmful effect that was not identified during prior safety-assessment studies. We developed a new technique for the measurements of repolarization abnormalities from surface ECGs; this method improves sensitivity and specificity of the current technique used to identify the presence of abnormal ion current kinetics in the myocardial cells namely a prolongation of the QT interval on the surface ECG signal. We described in this paper the method and preliminary results, revealing the superiority of our technique that may play a role in the future of drug-safety assessment
Engineering in Medicine and Biology Society, 2006. EMBS '06. 28th Annual International Conference of the IEEE; 10/2006
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[show abstract]
[hide abstract]
ABSTRACT: Several important non-cardiac drugs have been removed from the market after revealing harmful effect that was not identified during prior safety-assessment studies. We developed a new technique for the measurements of repolarization abnormalities from surface ECGs; this method improves sensitivity and specificity of the current technique used to identify the presence of abnormal ion current kinetics in the myocardial cells namely a prolongation of the QT interval on the surface ECG signal. We described in this paper the method and preliminary results, revealing the superiority of our technique that may play a role in the future of drug-safety assessment.
Conference proceedings: ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Conference 02/2006; 1:4010-5.
