Clinical added value of triplicate electrocardiograms: a review of 505 triplicate sets.

Abstract

Triplicate electrocardiograms (ECGs) are routinely included in clinical trials where concern of agent-induced electrophysiological alterations arise. Three electrocardiograms (triplicate ECGs) are obtained over a time interval of less than 10 min with the intent to increase recognition of changes, and to provide increased data for measurement and review of physiologic intervals. We undertook a prospective review of over 500 sets of triplicate ECGs to evaluate the added value of two additional tracings over a single ECG. Our review was done exclusively to evaluate the actual ECG tracings and not the reproducibility of the electronic interpretive algorithms. All ECGs were reviewed by one of the cardiologists over a four-month period. We found no meaningful changes in R-R, P-R, or Q-T intervals, nor any change in the QRS duration that was observed during the ≤ 10-minute period of data acquisition; rare supraventricular and ventricular ectopy was noted in 4 of the 505 triplicate sets. The routine inclusion of a requirement for triplicate ECGs should be revaluated to assess the added value to the patient or clinical research as well as potential burdens to the patient and financial impact.