J. Videbaek et al., THE TRANDOLAPRIL CARDIAC EVALUATION (TRACE) STUDY - RATIONALE, DESIGN, AND BASE-LINE CHARACTERISTICS OF THE SCREENED POPULATION, The American journal of cardiology, 73(10), 1994, pp. 30000044-30000050
The TRAndolapril Cardiac Evaluation (TRACE) study is evaluating the ef
fect of angiotensin-converting enzyme inhibition with trandolapril on
mortality (overall and cardiovascular) and cardiovascular morbidity in
patients surviving myocardial infarction (MI) with reduced left ventr
icular (LV) function. TRACE is a randomized, double-blind, placebo con
trolled study conducted in 27 centers in Denmark. Eligible patients ha
d a MI verified by elevated cardiac enzymes, electrocardiographic chan
ges, and/or chest pain as well as reduced LV function, as shown by ele
ctrocardiographic evaluation of wall motion index less than or equal t
o 1.2. (A wall motion index less than or equal to 1.2 approximates to
a left ventricular ejection fraction less than or equal to 35%.) Patie
nts with residual ischemia and/or heart failure were not excluded. Tra
ndolapril 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 less
than or equal to 1.2; of these, 1,749 were included. Overall 1-year m
ortality of the patients entered into the study was 24%. Treatment wil
l 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 de
mographic features of the screened population are described.