PMID- 8039405
OWN - NLM
STAT- MEDLINE
DCOM- 19940824
LR  - 20191023
IS  - 0197-2456 (Print)
IS  - 0197-2456 (Linking)
VI  - 15
IP  - 3
DP  - 1994 Jun
TI  - Survival of myocardial infarction long-term evaluation (SMILE) study: rationale, 
      design, organization, and outcome definitions.
PG  - 201-10
AB  - The rationale, design, organization, and outcome definitions of the Survival of 
      Myocardial Infarction Long-term Evaluation (SMILE) study are described in detail. 
      Recruitment of a total of 1500 patients (750 per treatment group) has been 
      planned for this multicenter, double-masked, randomized, placebo-controlled trial 
      investigating the effects of oral treatment with zofenopril calcium (7.5-30 mg 
      twice a day) on the combined short-term total mortality and occurrence of severe 
      refractory congestive heart failure in patients with acute anterior myocardial 
      infarction (AMI). Secondary outcomes of the study include recurrent myocardial 
      infarction, angina, and progression of congestive heart failure, as well as 
      long-term mortality. Patients are initially treated in hospital within 24 hr from 
      the onset of symptoms of AMI and their active follow-up is continued for 6 weeks. 
      In addition, the patients will be passively followed for 12 months from the index 
      AMI to assess vital status and the occurrence of congestive heart failure. The 
      trial data are analyzed on an intention-to-treat basis. An international 
      independent policy and safety monitoring board is acting as the overall 
      supervisory body and is responsible for the ethical conduct of the trial. A 
      scientific committee is responsible for the scientific aspects of the trial and 
      for the regular review of the progress of the study.
FAU - Ambrosioni, E
AU  - Ambrosioni E
AD  - Department of Internal Medicine, University of Bologna, Italy.
FAU - Borghi, C
AU  - Borghi C
FAU - Magnani, B
AU  - Magnani B
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Control Clin Trials
JT  - Controlled clinical trials
JID - 8006242
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 290ZY759PI (zofenopril)
RN  - 9G64RSX1XD (Captopril)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Angiotensin-Converting Enzyme Inhibitors/administration & dosage/adverse effects
MH  - Captopril/administration & dosage/adverse effects/*analogs & derivatives
MH  - Double-Blind Method
MH  - Female
MH  - Heart Failure/drug therapy/mortality
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/*drug therapy/mortality
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 1994/06/01 00:00
MHDA- 1994/06/01 00:01
CRDT- 1994/06/01 00:00
PHST- 1994/06/01 00:00 [pubmed]
PHST- 1994/06/01 00:01 [medline]
PHST- 1994/06/01 00:00 [entrez]
AID - 0197-2456(94)90057-4 [pii]
AID - 10.1016/0197-2456(94)90057-4 [doi]
PST - ppublish
SO  - Control Clin Trials. 1994 Jun;15(3):201-10. doi: 10.1016/0197-2456(94)90057-4.