Digital assessment of the epicardial electrocardiogram: novel methodology for a core laboratory for clinical studies.

BACKGROUND: The epicardial electrocardiogram (ECG) is a sensitive marker for cardiac ischemia and has been used as a measure of ischemia in clinical trials. We sought to examine the utility of a central ECG laboratory for determining ischemic-type ST-segment shifts from epicardial ECG recordings obtained from multiple clinical sites. HYPOTHESIS: We speculated that an operator-assisted digital ECG core laboratory is feasible, reliable, and efficient, with the ability for rapid and accurate interpretation of the epicardial ECG. METHODS: The epicardial ECG was recorded via an angioplasty guidewire placed in a coronary artery of a patient undergoing angioplasty. Site investigators visually determined the time-to-onset of 0.1 and 0.3 mm ST-segment elevation, and the maximal ST-segment elevation during balloon inflation, and then compared the measurements with those made at an operator-assisted digital ECG core laboratory. RESULTS: Agreement between the two methods occurred in 78% of the time-to-onset measurements, but in only 39% of the maximal ST-segment measurements. Overall, the visual measurements of the clinical investigators of time-to-onset differed from the digital core laboratory by 11.8 +/- 11.6 s for 0.1 mV, and 15.8 +/- 20.6 s for 0.3 mV. Recorded maximal ST-segment shifts differed by a mean of 0.47 +/- 0.69 mV. CONCLUSION: The magnitude of inconsistency between the ECG core laboratory results using an operator-assisted digital method and the interpretations of clinical investigators using manual caliper-type analysis was surprisingly large. These results support the need for an ECG core laboratory in clinical trials where ECG ST-segment shifts are used as a response variable.

Effect of precordial electrocardiographic electrode placement on ST-segment measurement during exercise.

Research protocols often utilize serial exercise testing to examine the efficacy of anti-ischemic therapies. These tests, however, are prone to multiple sources of bias. This investigation sought to determine the influence of varying precordial electrocardiographic (ECG) electrode placement on the detection of exercise-induced ST-segment shifts. Fifteen coronary artery disease patients with abnormal exercise tests were studied. Based on the previous exercise test, the precordial electrode position exhibiting the greatest ST-segment shift was selected as the reference electrode. Four additional electrodes were placed around this reference electrode and exercise testing was performed. ECG strips were recorded every minute. The time-to-onset and -offset of ischemic-type ST-segment depression was recorded. ST-segment depression was recorded during exercise from the reference electrode in 12 of 15 patients. Ischemic-type ST-depression was also recorded in each of these 12 patients with the surrounding electrodes; however, the time-to-onset detected by all four surrounding electrodes concurred in only 5 of 12 (42%) patients. The time-to-offset of the ST-segment depression concurred in 9 of 12 (75%) patients. Serial ECGs recorded from similar but not exactly the same precordial ECG electrode position should yield similar results for the detection of ischemia, but time-to-onset or -offset of ischemia may differ by 60 s or more. Small changes in the time-to-onset and -offset of ischemia should not be considered reliable indicators of anti-ischemia efficacy.