THE TRANDOLAPRIL CARDIAC EVALUATION (TRACE) STUDY - RATIONALE, DESIGN, AND BASE-LINE CHARACTERISTICS OF THE SCREENED POPULATION

Citation
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
Citations number
17
Categorie Soggetti
Cardiac & Cardiovascular System
ISSN journal
00029149
Volume
73
Issue
10
Year of publication
1994
Pages
30000044 - 30000050
Database
ISI
SICI code
0002-9149(1994)73:10<30000044:TTCE(S>2.0.ZU;2-Q
Abstract
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.