Clinical Characteristics and Mortality of Patients Screened for Entry Into the Trandolapril Cardiac Evaluation (TRACE) Study
Section snippets
Methods
Patients: Details of the Trandolapril Cardiac Evaluation (TRACE) protocol have been published elsewhere.6 TRACE is a randomized, placebo-controlled, double-blind, parallel-group trial of the ACE inhibitor trandolapril among patients with LV systolic dysfunction shortly after an AMI. The primary end point of the trial is all-cause mortality.
In brief, consecutive patients with an enzyme confirmed AMI in 27 Danish hospitals were screened. An echocardiography and a medical history were obtained. LV
Results
A total of 7,001 enzyme-confirmed myocardial infarctions were screened for entry into the study at the 27 participating centers. The 7,001 infarctions represented 6,676 patients: 272 patients were screened twice, 19 three times, and 5 four times. Descriptive statistics of the 7,001 infarctions are listed in Table II. In this table, the numbers refer to infarctions, not patients. However, if descriptive statistics are calculated corresponding to initial infarction, the result is nearly the same:
Discussion
The 1-year mortality of patients with AMI screened for entry into TRACE and of those finally randomized were very similar, 23% and 24%. With regard to other studies attempting to randomize high-risk patients, a question is raised as to the possibility of extrapolating the result of the trial beyond those randomized.
The 7,001 AMIs screened for entry into TRACE were representative of the general population with AMI admitted alive to the hospital when 1-year mortality results are compared with
Acknowledgment
We thank Laurent Auclair, MD, and David Cole, PhD, for their helpful comments.
References (10)
- et al.
Early estimation of risk by echocardiographic determination of wall motion index in an unselected population with acute myocardial infarction
Am J Cardiol
(1990) - et al.
Applying results of randomized trials to clinical practice: impact of losses before randomization
Br Med J
(1984) - et al.
Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the Survival and Ventricular Enlargement trial
N Engl J Med
(1992) The effect of ramipril on mortality and morbidity of survival of acute myocardial infarction with clinical evidence of heart failure
Lancet
(1993)- et al.
Short and long term prognosis of acute myocardial infarction since introduction of thrombolysis
Br Med J
(1993)
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The Trandolapril Cardiac Evaluation study was sponsored by Roussel UCLAF, Romainville, France, and Knoll AG, Ludwigshafen, Germany