The TRAndolapril Cardiac Evaluation (TRACE) study: rationale, design, and baseline characteristics of the screened population. The Trace Study Group.
The TRAndolapril Cardiac Evaluation (TRACE) study is evaluating the effect of angiotensin-converting enzyme inhibition with trandolapril on mortality (overall and cardiovascular) and cardiovascular morbidity in patients surviving myocardial infarction (MI) with reduced left ventricular (LV) function. TRACE is a randomized, double-blind, placebo-controlled study conducted in 27 centers in Denmark. Eligible patients had a MI verified by elevated cardiac enzymes, electrocardiographic changes, and/or chest pain as well as reduced LV function, as shown by echocardiographic evaluation of wall motion index < or = 1.2. (A wall motion index < or = 1.2 approximates to a left ventricular ejection fraction < or = 35%). Patients with residual ischemia and/or heart failure were not excluded. Trandolapril or placebo was added to conventional therapy 3-7 days after MI. Between May 1990 and June 1992, 6,674 patients (7,010 infarctions) were screened. A total of 2,614 patients had a wall motion index < or = 1.2; of these, 1,749 were included. Overall 1-year mortality of the patients entered into the study was 24%. Treatment will be continued for 2-4 years (mean, 3 years), ending in mid 1994. The design and organization of the study, the outcome of screening, and demographic features of the screened population are described.
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004452:Echocardiography; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D016277:Ventricular Function, Left / Q000187:drug effects*
D000806:Angiotensin-Converting Enzyme Inhibitors; D007211:Indoles; C052035:trandolapril