Novel probabilistic method for precisely correcting the QT interval for heart rate in telemetered dogs and cynomolgus monkeys

Journal of Pharmacological and Toxicological Methods

Volumn 55, Issue 2, 2007, Pages 159-175

  Holzgrefe, Henry H ^a   Cavero, Icilio ^b   Gleason, Carol R ^a   Warner, William A ^a   Buchanan, Lewis V ^a   Gill, Michael W ^a   Burkett, Dennis E ^a   Durham, Stephen K ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

^b Safety Pharmacology Advisor   (Italy)

Author keywords

Beagle dog; Cynomolgus monkey; ECG; Epicardial; Methods; Probability; QT prolongation; QT rate correction; Telemetry

Indexed keywords

ACCURACY; ALGORITHM; ANIMAL EXPERIMENT; ARTICLE; DOG; ELECTROCARDIOGRAM; EPICARDIUM; FEMALE; HEART BEAT; HEART RATE; HEART REPOLARIZATION; HYSTERESIS; MALE; MONKEY; NONHUMAN; PROBABILITY; QT INTERVAL; RR INTERVAL; SENSITIVITY AND SPECIFICITY; TELEMETRY;

ALGORITHMS; ANIMALS; CALIBRATION; CIRCADIAN RHYTHM; DATA INTERPRETATION, STATISTICAL; DOGS; ELECTROCARDIOGRAPHY; FEMALE; HEART RATE; LONG QT SYNDROME; MACACA FASCICULARIS; MALE; MODELS, STATISTICAL; TELEMETRY;

CANIS FAMILIARIS; MACACA FASCICULARIS;

EID: 33846886709     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2006.05.007     Document Type: Article

References (36)

1. Batchvarov N.V., Ghuran A., Smetana P., Hnatkova K., Harries M., Dilaveris P., et al. QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability. American Journal of Physiology. Heart and Circulatory Physiology 282 (2002) H2356-H2363
2. Bazett H.C. An analysis of the time relations of electrocardiograms. Heart 7 (1920) 353-370
3. Cavero I., and Crumb W. The use of electrocardiograms in clinical trials: A public discussion of the proposed ICH E14 regulatory guidance. April 11-12, 2005, Bethesda, MD, USA. Expert Opinion on Drug Safety 4 (2005) 795-799
4. Cavero I., and Crumb W. Moving towards better predictors of drug-induced torsade de pointes. 2-3 November 2005, Crystal City, Virginia, USA. Expert Opinion on Drug Safety 5 (2006) 335-340
5. Chaves, A. A., Keller, W. J., O'Sullivan, S., Williams, M. A., Fitzgerald, L. E., McPherson, H. E., et al. (in press). Cardiovascular monkey telemetry: Sensitivity to detect QT interval prolongation. Journal of Pharmacological and Toxicological Methods.
6. Emori T., and Antzelevitch C. Cellular basis for complex T waves and arrhythmic activity following combined I(Kr) and I(Ks) block. Journal of Cardiovascular Electrophysiology 12 (2001) 1369-1378
7. Extramiana F., Maison Blanche P., Badilini F., Pinoteau J., Deseo T., and Coumel P. Circadian modulation of QT rate dependence in healthy volunteers: Gender and age differences. Journal of Electrocardiology 32 (1999) 33-43
8. Extramiana F., Tavernier R., Maison Blanche P., Neyroud N., Jordaens L., Leenhardt A., et al. Ventricular repolarization and Holter monitoring. Effect of sympathetic blockage on the QT/RR ratio. Archives des Maladies du Coeur et des Vaisseaux 93 (2000) 1277-1283
9. Fossa A.A., DePasquale M.J., Raunig D.L., Avery-Michael J., and Leishman Derek J. The relationship of clinical QT prolongation to outcome in the conscious dog using a beat-to-beat QT-RR interval assessment. The Journal of Pharmacology and Experimental Therapeutics 302 (2002) 828-833
10. Fossa A.A., Wisialowski T., and Crimin K. QT prolongation modifies dynamic restitution and hysteresis of the beat-to-beat QT-TQ interval relationship during normal sinus rhythm under varying states of repolarization. The Journal of Pharmacology and Experimental Therapeutics 316 (2006) 498-506
11. Fossa A.A., Wisialowski T., Magnano A., Wolfgang E., Winslow R., Gorczyca W., et al. Dynamic beat-to-beat modeling of the QT-RR interval relationship: Analysis of QT prolongation during alterations of autonomic state versus human ether a-go-go-related gene inhibition. The Journal of Pharmacology and Experimental Therapeutics 312 (2004) 1-11
12. Fossa A.A., Wisialowski T., Magnano A., Wolfgang E., Winslow R., Gorczyca W., et al. Dynamic beat-to-beat modeling of the QT-RR interval relationship: Analysis of QT prolongation during alterations of autonomic state versus human ether a-go-go-related gene inhibition. The Journal of Pharmacology and Experimental Therapeutics 312 (2005) 1-11
13. Fridericia L.S. Die systolendauer im elecktrokardiogramm bei normalen menschen und bei herzkranken. Acta Medica Scandinavica (1920) 469-486
14. Gauvin D.V., Tilley L.P., Smith Francis Jr. W.K., and Baird-Theodore J. Electrocardiogram, hemodynamics, and core body temperatures of the normal freely moving cynomolgus monkey by remote radiotelemetry. Journal of Pharmacological and Toxicological Methods 53 (2006) 140-151
15. Gauvin D.V., Tilley L.P., Smith Francis Jr. W.K., and Baird-Theodore J. Electrocardiogram, hemodynamics, and core body temperatures of the normal freely moving laboratory beagle dog by remote radiotelemetry. Journal of Pharmacological and Toxicological Methods 53 (2006) 128-139
16. Hamlin R.L. Non-drug-related electrocardiographic features in animal models in safety pharmacology. Journal of Pharmacological and Toxicological Methods 52 (2005) 60-76
17. Hamlin R.L., Kijtawornrat A., and Keene B.W. How many cardiac cycles must be measured to permit accurate RR, QT, and QTc estimates in conscious dogs?. Journal of Pharmacological and Toxicological Methods 50 (2004) 103-108
18. Lang T.A., and Secic M. How to report statistics in medicine: Annotated guidelines for authors, editors, and reviewers (1997), Versa Press
19. Mace A.E. Sample-size determination (1974), E. Kreiger Publishing Company, Huntington, NY
20. Malik M. Problems of heart rate correction in assessment of drug-induced QT interval prolongation. Journal of Cardiovascular Electrophysiology 12 (2001) 411-420
21. Malik M. Errors and misconceptions in ECG measurement used for the detection of drug induced QT interval prolongation. Journal of Electrocardiology (2004) 25-33
22. Malik M. Assessment of drug-induced QT prolongation: To bin or not to bin?. Clinical Pharmacology and Therapeutics 77 (2005) 241-246
23. Malik M., Farbom P., Batchvarov V., Hnatkova K., and Camm A.J. Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval. Heart (British Cardiac Society) 87 (2002) 220-228
24. Malik M., Hnatkova K., Batchvarov V., Gang Y., Smetana P., and Camm A.J. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing and Clinical Electrophysiology 27 (2004) 1659-1669
25. Miyazaki H., and Tagawa M. Rate-correction technique for QT interval in long-term telemetry ECG recording in beagle dogs. Experimental Animals 51 (2002) 465-475
26. Neter J., and Wasserman W. Aptness of model and remedial measures. Applied linear statistical models (1974), Richard D. Irwin Inc, Homewood, IL 97-107
27. Nygren A., Kondo C., Clark R.B., and Giles W.R. Voltage-sensitive dye mapping in Langendorff-perfused rat hearts. American Journal of Physiology. Heart and Circulatory Physiology 284 (2003) H892-H902
28. Ollerstam, A., Persson, A.H., Visser, S.A.G., Fredriksson, J.M., Forsberg, T., Nilsson, L.B., Eklund, G., et al. (in press). A novel approach to data processing of the QT interval response in the conscious telemetered beagle dog. Journal of Pharmacological and Toxicological Methods.
29. Pueyo E., Smetana P., Laguna P., and Malik M. Estimation of the QT/RR hysteresis lag. Journal of Electrocardiology 36 (2003) 187-190
30. Shah R.R. Drugs, QT interval prolongation and ICH E14: The need to get it right. Drug Safety 28 (2005) 115-125
31. Shimizu W., and Antzelevitch C. Cellular basis for the ECG features of the LQT1 form of the long-QT syndrome: Effects of beta-adrenergic agonists and antagonists and sodium channel blockers on transmural dispersion of repolarization and torsade de pointes. Circulation 98 (1998) 2314-2322
32. Shimizu W., and Antzelevitch C. Cellular and ionic basis for T-wave alternans under long-QT conditions. Circulation 99 (1999) 1499-1507
33. Smetana P., Batchvarov V., Hnatkova K., Camm A.J., and Malik M. Circadian rhythm of the corrected QT interval: Impact of different heart rate correction models. Pacing and Clinical Electrophysiology: Pace 26 (2003) 383-386
34. Spence S., Soper K., Hoe C.M., and Coleman J. The heart rate-corrected QT interval of conscious beagle dogs: A formula based on analysis of covariance. Toxicological Sciences 45 (1998) 247-258
35. Streiner D.L., and Norman G.R. "Precision" and "accuracy": Two terms that are neither. Journal of Clinical Epidemiology 59 (2006) 327-330
36. Yan G.X., and Antzelevitch C. Cellular basis for the normal T wave and the electrocardiographic manifestations of the long-QT syndrome. Circulation 98 (1998) 1928-1936