RESUMO
The objective of the European Myocardial Infarct Amiodarone Trial (EMIAT) is to assess the efficacy of amiodarone on mortality of patients with depressed left ventricular (LV) function following myocardial infarction (MI). The rationale for the trial is as follows: patients with poor LV function after acute MI have a high sudden cardiac death (SCD) mortality; amiodarone is a successful prophylactic therapy against SCD in patients with ventricular arrhythmias; a number of small studies (Canadian Amiodarone Myocardial Infarction Arrhythmia Trial [CAMIAT] pilot study, Basel Antiarrhythmic Study & Infarct Survival [BASIS], and the Polish Amiodarone Trial [PAT]) of prophylactic amiodarone post AMI have shown a beneficial response attributable to amiodarone. Patients are enrolled between 5 and 21 days after acute MI if LV ejection fraction (assessed by multiple-gated image acquisition nuclear angiography) is < or = 40%. The study group is stratified according to ejection fraction (stratum 1, 31-40%; stratum 2, < 31%). Amiodarone or placebo treatment (blind, randomized) is initiated prior to the discharge of the patient from the hospital and each patient is followed up for the duration of the study, at least 1 year. Recruitment began on November 30, 1990, and will continue for 4 years; > 700 patients are enrolled from > 60 centers (13 countries). The total study mortality (10% at 500 days) and the differential mortality of both strata are as anticipated. Side effects have been infrequent and very few patients have been withdrawn from the study. Trial conclusion is forecast for October 1995.
