Electrocardiography and repolarization abnormalities in cardiac safety: Benefits and limitations of fully automated methods for QT measurement

Computing in Cardiology

Volumn 37, Issue , 2010, Pages 253-256

  Kligfield, Paul ^a,b  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b WEILL CORNELL MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTOMATED MEASUREMENT; AUTOMATED METHODS; DRUG SAFETY; ENGINEERING SOLUTIONS; POTENTIALLY FATAL; QT PROLONGATION; REPOLARIZATION; T WAVES; VENTRICULAR REPOLARIZATION;

ALGORITHMS; AUTOMATION; CARDIOLOGY; ELECTROCARDIOGRAPHY; ELECTROCHROMIC DEVICES; SAFETY ENGINEERING;

SAFETY TESTING;

EID: 79953823903     PISSN: 23258861     EISSN: 2325887X     Source Type: Conference Proceeding    
DOI: None     Document Type: Conference Paper

References (10)

1. Roden DM. Drug-induced prolongation of the QT Interval. NEJM 2004;350:1013-1022. (Pubitemid 38269278)
2. Shah RR. Drugs, QTc interval prolongation and final ICH E14 guideline: an important milestone with challenges ahead. Drug Safety 2005;28:1009-10028.
3. Food and Drug Administration, HHS. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice. Fed Regist. 2005;70(202):61134-5.
4. Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrythmic Drugs. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default. htm
5. Kligfield P, Gettes LS, Bailey JJ, Childers R, Deal BJ, Hancock EW, van Herpen G, Kors JA, Macfarlane P, Mirvis DM, Pahlm O, Rautaharju P, Wagner GS. Recommendations for the standardization and interpretation of the electrocardiogram: part I: The electrocardiogram and its technology: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society: endorsed by the International Society for Computerized Electrocardiology. Circulation 2007;115:1306-24. (Pubitemid 46594775)
6. Kligfield P, Tyl B, Maarek M, Maison-Blanche PMB. Magnitude, mechanism, and reproducibility of QT interval differences between superimposed global and individual lead ECG complexes. Annals of Noninvasive Electrocardiology 2007;12:1-8.
7. Kligfield P, Hancock EW, Helfenbein ED, Dawson EJ, Cook MA, Lindauer JM, Zhou SH, Xue J. Relation of QT interval measurements to evolving automated algorithms from different manufacturers of electrocardiographs. American Journal of Cardiology 2006;98;88-92. (Pubitemid 43902688)
8. Tyl B, Kabbaj M, Fassi B, DeJode P, Wheeler W. Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: variability and sample size considerations. J Clin Pharmacol 2009;49:905-915.
9. Serapa N, Gussak I, Vajdic B, George S, Hadzievski L, Francom SF, Kowey P. Comparison of QTinno, a fully automated electrocardiographic analysis program, to semiautomated eelectrocardiographic analysis methods in a drug safety study in healthy subjects. J Elecrtrocardiol 2009;42:358-366
10. CSRC Scientific Rationale and Mission Statement. http://www.cardiac- safety.org/about-us, accessed June 10, 2010