How to obtain and analyze electrocardiograms in clinical trials: Focus on issues in measuring and interpreting changes in the QT(c) interval duration

Annals of Noninvasive Electrocardiology

Volumn 4, Issue 4, 1999, Pages 425-433

  Morganroth, Joel ^a   Silber, Steven S ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Clinical research; Core laboratory; CPMP guidelines; Electrocardiogram (ECG); QT(c) interval

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COST EFFECTIVENESS ANALYSIS; DATA ANALYSIS; ELECTROCARDIOGRAPHY; LABORATORY; PRIORITY JOURNAL; QT INTERVAL;

EID: 0033432687     PISSN: 1082720X     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1542-474X.1999.tb00233.x     Document Type: Article

References (13)

1. 1. Monahan BP, Ferguson CL, Killeavy ES, et al. Torsades de pointes occurring in association with terfenadine use. JAMA 1990:264:2788-2790.
2. C interval: impact on denning drug effect and low-frequency cardiac events. Am J Cardiol 1993;72:26B-31B.
3. 3. Honig PK, Wortham DC, Zamani K, et al. Terfenadine-ketoconazole interaction: Pharmacokinetic and electrocardiographic consequences. JAMA 1993:269:1513-1518.
4. 4. Willems JL. The Diagnostic performance of computer programs for interpretation of electrocardiograms. New Engl J Med 1991;324:1767-1773.
5. 5. Montgomery H, Hunter S, Morris S, et al. Interpretation of electrocardiograms by doctors. Br Med J 1994;309:1551-1552.
6. 6. Botstein, P. Is QT Interval prolongation harmful? A regulatory perspective. Am J Cardiol 1993;72:50B-52B.
7. 7. Jaillon P, Morganroth J, Brumpt I, et al. and the Sparfloxacin Safety Group: Overview of electrocardiographic and cardiovascular safety data for sparfloxacin. J Antimicrob Chemother 1996;37:161-167.
8. 8. Committee for Proprietary Medicinal Products. Points to Consider: The Assessment of the Potential for QT Interval Prolongation by Non-Cardiovascular Medicinal Products. The European Agency for the Evaluation of Medicinal Products. December, 1997.
9. 9. Bazett HC. An analysis of the time relation of electrocardiograms. Heart 1920;7:353-370.
10. 10. Ahnve S. Correction of the QT interval for heart rate: Review of different formulas and the use of the Bazett's formula in myocardial infarction. Am Heart J 1985;109:568-574.
11. 11. Morganroth J, Brozovich FV, McDonald JT, et al. Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiol 1991;67:774-776.
12. C interval on the scalar electrocardiogram: Distinguishing a drug effect from spontaneous variability. Am Heart J 1996;131: 472-80.
13. 13. Zabel M, Klingenheben T, Franz MR, et al. Assessment of QT dispersion for prediction of mortality or arrhythmic events after myocardial infarction. Circulation 1998;97:2543-2550.