Poulsen 1999.
Study characteristics | ||
Methods | Randomised clinical trial at a single site in Denmark between September 1993 and January 1995 | |
Participants | 77 participants with acute MI defined as creatinine kinase ≥ 210 IU and creatinine kinase B ≥ 20 IU or electrocardiographic evidence of MI (ST elevation > 1 mm in contiguous leads or subendocardial injury pattern) and typical chest pain were eligible for the study. Furthermore, all patients had LVEF > 40% at baseline and were between 40 and 75 years of age Male:female = 58:19 Mean age = 61.5 years Exclusion criteria: ongoing treatment with beta‐blockers, systolic blood pressure < 100 mmHg, heart rate < 50 beats/min, intermittent claudication, significant valvular heart disease, severe obstructive lung disease, appearance of atrioventricular block of second or third degree, uncontrolled diabetes mellitus, severe uncontrolled congestive heart failure, other life‐threatening disease |
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Interventions | Treatment begun 5 to 7 days after admission Experimental group: metoprolol 200 mg for 12 months (n = 39) Control group: placebo for 12 months (n = 38) Co‐intervention: none mentioned Excluded medication: none mentioned |
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Outcomes | Outcomes: cardiac mortality, ejection fraction, cardiovascular parameters Time points reported: 3, 6, and 12 months |
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Notes | Study authors were contacted at steepoul@rm.dk on 20‐06‐2017. No response was received Randomisation took place 5 to 7 days after admission with acute myocardial infarction Study reported only 'sudden cardiac mortality'; because no other deaths were reported, we used this as our all‐cause mortality MACE was not reported nor calculated because no data were available Study was funded by the Danish Heart Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described sufficiently, other than "patients were randomly assigned to receive either metoprolol (200 mg) or placebo" |
Allocation concealment (selection bias) | Unclear risk | Not described sufficiently, other than "patients were randomly assigned to receive either metoprolol (200 mg) or placebo" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described; however, the study was described as double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Echocardiographic data were analyzed by one author (S.H.P.) blinded to the patients’ clinical data" However, assessment of mortality was not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is not described whether any participants were lost to follow‐up. Only withdrawals were described |
Selective reporting (reporting bias) | Unclear risk | No protocol was found; however mortality and serious adverse events were reported |
Other bias | Low risk | No other biases were found |