DIFFERENCES BETWEEN LOCAL INVESTIGATOR AND CORE LABORATORY INTERPRETATION OF THE ADMISSION ELECTROCARDIOGRAM IN PATIENTS WITH UNSTABLE ANGINA-PECTORIS OR NON-Q-WAVE MYOCARDIAL-INFARCTION (A THROMBIN INHIBITIONIN MYOCARDIAL-ISCHEMIA [TRIM] SUBSTUDY)

The present study compares the on-site interpretation of an admission electrocardiogram (ECG) with core laboratory results in a large, multi center trial of 516 patients diagnosed with unstable angina pectoris o r non-Q-wave myocardial infarction. The local investigators evaluated the admission ECG regarding ST-T changes before the ECGs were sent to the core laboratory for blinded interpretation. The strength of agreem ent between the observations was described by kappa statistics. There was a poor agreement regarding identification of ST-segment elevation, with 17 patients identified by the local investigator versus 92 by th e core laboratory (kappa = 0.05), There was a fair agreement on ST-seg ment depression with 158 patients diagnosed on-site versus 64 by the c ore laboratory (kappa = 0.38). Identification of T-wave inversion demo nstrated good agreement with 306 patients diagnosed on-site versus 280 by the core laboratory (kappa = 0.63) A moderate agreement regarding identification of a normal ECG was found with 101 patients on-site ver sus 135 in the core laboratory (kappa = 0.42), Independent variables, including peak creatine kinase-MB and 30-day outcome, were more closel y related to core laboratory results than the local investigator's int erpretation of the admission EGG. Thus, in the present study, consider able differences were demonstrated between the on-site interpretation of the admission ECG and the blinded evaluation performed in the core laboratory regarding relatively simple electrocardiographic variables. The results suggest that more widespread use of independent evaluatio n of clinical data should be incorporated in future clinical trials. ( C) 1998 by Excerpta Medico, Inc.