European heart journal
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European heart journal · Jun 1993
Randomized Controlled Trial Comparative Study Clinical TrialThe incidence and mechanism of hypotension following thrombolytic therapy for acute myocardial infarction with streptokinase-containing agents--lack of relationship to pretreatment streptokinase resistance.
The incidence, amplitude, mechanism and relationship to prior exposure to streptococcal antigen of blood pressure changes to streptokinase-containing thrombolytic agents were investigated in 125 patients treated with either 1.5 x 10(6) IU streptokinase over 60 min or 30 U anistreplase over 5 min, within 6 h of onset of acute myocardial infarction. Twenty-one of 52 patients with anterior and 34 of 73 with inferior myocardial infarction had a hypotensive response. There were no significant differences in the incidence, duration or amplitude of hypotension between the two treatment groups. ⋯ Hypotension was not related to pretreatment streptokinase resistance titre, or anti-SK IgG concentration, to changes in plasma fibrinogen, B-beta 15-42 peptide, D-dimer--as indices of thrombin activation and fibrin (-ogen) breakdown--to plasma viscosity. The blood pressure changes following treatment with streptokinase-containing thrombolytic agents in acute myocardial infarction are frequent but well tolerated. The mechanism of hypotension remains unclear, but is not related to prior exposure to streptococcal antigen.
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European heart journal · Feb 1993
Randomized Controlled Trial Clinical TrialThe influence of intravenous magnesium sulphate on the occurrence of atrial fibrillation after coronary artery by-pass operation.
To examine the influence of magnesium (Mg) on hypomagnesaemia and atrial fibrillation (AF) following coronary artery by-pass surgery, 140 consecutive patients were randomized to receive 70 mmol of magnesium sulphate intravenously (n = 69) or placebo (n = 71). Serum magnesium concentrations fell to 0.77 +/- 0.10 mmol.l-1 in the control group but rose to 1.09 +/- 0.17 mmol.l-1 in the Mg group (P < 0.001). The incidence of AF was 29% in the Mg group and 26% in the placebo group (NS). ⋯ In the Mg group, serum Mg and SR were the only independent predictors of AF. In conclusion, the incidence of post-operative AF is not decreased with magnesium. High Mg levels are likely to provoke AF probably by mechanisms that modify SR.
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European heart journal · Aug 1989
Randomized Controlled Trial Clinical TrialA randomized prospective study on anxiety reduction by preparatory disclosure with and without video film show about a planned heart catheterization.
Unfortunately, giving preparatory information to the patient is generally regarded as legally mandatory for obtaining his written consent to an invasive procedure. Disclosure, however, could be used to reduce his anxiety as well; we hypothesized that showing a preparatory video film might be helpful in this respect. Patients who were admitted for elective coronary angiography were eligible for the study. 65 were randomized to two groups: both groups received the same leaflet and personal interview with the doctor, but only one group (Group 2) additionally watched a 14 min preparatory video. ⋯ The two groups did not differ with respect to initial anxiety levels and other important parameters. Group 1 patients, who did not watch the video had no significant reduction in anxiety score; group 2 patients showed a significant benefit. We conclude that disclosure with the additional aid of a video film may be an easy, yet effective way to reduce patients' anxiety.
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European heart journal · Oct 1987
Randomized Controlled Trial Clinical TrialThe Lopressor Intervention Trial: multicentre study of metoprolol in survivors of acute myocardial infarction. Lopressor Intervention Trial Research Group.
The Lopressor Intervention Trial (LIT) was a double-blind, randomized, placebo-controlled, multicentre study designed to evaluate the effect of oral metoprolol on overall mortality in patients surviving a recent acute myocardial infarction. Patient enrollment began in August 1979 and ended on 15 April 1982, with 2395 patients (1200 on placebo and 1195 on metoprolol). Hospitalized patients, 45 to 74 years of age, began therapy from 6 to 16 days after their myocardial infarction. ⋯ After 1 year there were 62 deaths in the placebo group and 65 in the metoprolol group. Thus, the 1 year placebo mortality rate of 5.2% was half that predicted at the outset. In addition, study medication was prematurely discontinued in over 30% of patients in the metoprolol group.(ABSTRACT TRUNCATED AT 250 WORDS)
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European heart journal · Jun 1987
Randomized Controlled Trial Comparative Study Clinical TrialRandomized factorial trial of high-dose intravenous streptokinase, of oral aspirin and of intravenous heparin in acute myocardial infarction. ISIS (International Studies of Infarct Survival) pilot study.
619 patients with suspected acute myocardial infarction (MI) were randomized to receive either a high-dose short-term intravenous infusion of streptokinase (1.5 MU over one hour) or placebo. Using a '2 X 2 X 2 factorial' design, patients were also randomized to receive either oral aspirin (325 mg on alternate days for 28 days) or placebo, and separately randomized to receive either intravenous heparin (1000 IU h-1 for 48 hours) or no heparin. Streptokinase (SK) was associated with a nonsignificant (NS) increase in non-fatal reinfarction (3.9% SK vs 2.9% placebo) and decrease in mortality (7.5% vs 9.7% in hospital plus 6.1% vs 8.7% after discharge). ⋯ Aspirin was associated with fewer non-fatal reinfarctions (3.2% aspirin vs 3.9% placebo; NS), deaths (in hospital: 6.1% vs 10.5%; 2P less than 0.05, and after discharge: 7.0% vs 6.9%; NS), and strokes (0.3% vs 2.0%; NS). Heparin was associated with a decrease in reinfarction (2.2% heparin vs 4.9% no heparin; NS), though not in mortality (in hospital: 8.0% vs 8.5%; NS, and after discharge: 7.0% vs 6.9%; NS), and with a trend towards more strokes (1.6% vs 0.7%; NS) and more bruising and bleeding (14% vs 12%; NS). To assess more reliably the effects of aspirin and of this SK regimen on mortality, about 400 hospitals worldwide are now collaborating in a large (about 20,000 patients planned) randomized trial (ISIS-2), for which the present study was a pilot.