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The TRAndolapril Cardiac Evaluation (TRACE) study: rationale, design, and baseline characteristics of the screened
Insights
The TRACE study investigated trandolapril
Area of Science:
- Cardiology
- Pharmacology
Background:
- Myocardial infarction (MI) survivors with reduced left ventricular (LV) function face high mortality risks.
- Angiotensin-converting enzyme (ACE) inhibitors are a cornerstone of post-MI therapy.
Purpose of the Study:
- To evaluate the efficacy of trandolapril, an ACE inhibitor, in reducing mortality and cardiovascular morbidity.
- To assess the impact of trandolapril on patients surviving myocardial infarction with impaired LV function.
Main Methods:
- The TRACE study is a randomized, double-blind, placebo-controlled trial.
- 1,749 patients with MI and LV wall motion index ≤ 1.2 were enrolled across 27 Danish centers.
- Trandolapril or placebo was administered alongside conventional therapy 3-7 days post-MI.
Main Results:
- The study screened 6,674 patients between May 1990 and June 1992.
- 1,749 patients with reduced LV function were included in the trial.
- The overall 1-year mortality rate for enrolled patients was 24%.
Conclusions:
- The TRACE study provides crucial data on ACE inhibition in post-MI patients with LV dysfunction.
- Long-term outcomes of trandolapril treatment will be assessed over 2-4 years.
Abstract:
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.