The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Impact of time to treatment with tissue plasminogen activator on morbidity and mortality following acute myocardial infarction (The second National Registry of Myocardial Infarction).
This study examines the association between time to treatment with thrombolytic therapy and hospital outcomes in patients with acute myocardial infarction (AMI) enrolled in a national registry. A total of 71,253 patients hospitalized with AMI from June 1994 to July 1996 who received tissue plasminogen activator (t-PA) therapy in 1,474 United States hospitals were studied. In this study sample, approximately 39% of patients presented to participating hospitals within 2 hours of acute symptom onset and received t-PA; 36% were treated within 2.1 to 4 hours, 12% between 4.1 to 6 hours, and the remaining 13% thereafter. ⋯ The incidence of sustained ventricular arrhythmias declined with progressively longer time to administration of t-PA. The results of this multihospital observational study suggest that patients with AMI treated earlier with t-PA are significantly more likely to survive the acute hospitalization than patients treated later. These data reinforce the benefits to be gained by treatment with t-PA as soon as possible following the onset of acute ischemic symptoms, and for community-wide efforts to reduce the duration of prehospital delay in patients with acute coronary disease.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Differences between local investigator and core laboratory interpretation of the admission electrocardiogram in patients with unstable angina pectoris or non-Q-wave myocardial infarction (a Thrombin Inhibition in Myocardial Ischemia [TRIM] substudy).
The present study compares the on-site interpretation of an admission electrocardiogram (ECG) with core laboratory results in a large, multicenter trial of 516 patients diagnosed with unstable angina pectoris or non-Q-wave myocardial infarction. The local investigators evaluated the admission ECG regarding ST-T changes before the ECGs were sent to the core laboratory for blinded interpretation. The strength of agreement between the observations was described by kappa statistics. ⋯ Independent variables, including peak creatine kinase-MB and 30-day outcome, were more closely related to core laboratory results than the local investigator's interpretation of the admission ECG. Thus, in the present study, considerable differences were demonstrated between the on-site interpretation of the admission ECG and the blinded evaluation performed in the core laboratory regarding relatively simple electrocardiographic variables. The results suggest that more widespread use of independent evaluation of clinical data should be incorporated in future clinical trials.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Prospective comparison of flecainide versus sotalol for immediate cardioversion of atrial fibrillation.
This study sought to compare the efficacy and safety of intravenous flecainide and sotalol for immediate cardioversion of atrial fibrillation. We performed a prospective, randomized, single-blind, multicenter trial, including 106 hemodynamically stable patients with atrial fibrillation, stratified according to duration of the arrhythmia. Exclusion criteria included severely reduced left ventricular systolic function, recent antiarrhythmic therapy, and hypokalemia. ⋯ Overall, 28 of 54 patients (52%) given flecainide and 12 of 52 patients (23%) given sotalol converted to sinus rhythm during the first 2 hours after start of the infusion (p = 0.003). Multivariate analysis confirmed that treatment allocation to flecainide, an arrhythmia duration of < or = 24 hours, higher plasma magnesium level at baseline, higher age for men, and lower age for women independently increases the probability of conversion. The frequency of adverse effects was not significantly different in the 2 treatment groups.
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Randomized Controlled Trial Comparative Study Clinical Trial
In-hospital and late results of coronary stents versus conventional balloon angioplasty in acute myocardial infarction (GRAMI trial). Gianturco-Roubin in Acute Myocardial Infarction.
One hundred four patients presenting with acute myocardial infarction < 24 hours after onset were randomized to 2 groups: group I (n = 52) was treated with balloon angioplasty followed electively with Gianturco Roubin II stents, and group II was treated with conventional balloon angioplasty alone (n = 52). All lesions were suitable for stenting. Baseline clinical, demographic, and angiographic characteristics were similar in the 2 groups. ⋯ Repeat angiography performed routinely before hospital discharge revealed TIMI 3 flow in the infarct-related artery in 98% in group I versus 83% in group II, p < 0.03. At late follow-up, event-free survival was significantly better in the stent (83%) than in the coronary angioplasty (65%) group (p = 0.002). The procedural in-hospital and late outcomes of this randomized study demonstrate that balloon angioplasty followed electively by coronary stents can be used as the primary modality for patients undergoing coronary interventions for acute myocardial infarction, increasing TIMI 3 flow, reducing in-hospital adverse events, and improving late outcome compared with balloon angioplasty alone.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Design of a clinical trial for the assessment of cardioversion using transesophageal echocardiography (The ACUTE Multicenter Study). Steering and Publications Committees of the ACUTE Study.
Patients with atrial fibrillation (AF) undergoing cardioversion are at an increased risk of cardioembolic stroke and require anticoagulation. The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) Multicenter Study is a randomized clinical trial of patients undergoing electrical cardioversion of AF of >2 days' duration comparing a transesophageal-guided strategy (TEE) with brief anticoagulation to the conventional anticoagulation strategy. Patients randomly assigned to the TEE-guided strategy receive therapeutic anticoagulation before TEE and cardioversion, followed by 4 weeks of anticoagulation. ⋯ The anticipated rates of embolism of 2.9% for conventional strategy and 1.2% for the TEE-guided strategy are based on published research and the completed pilot study. The ACUTE Multicenter Study will randomize therapy and follow an estimated 3,000 patients from 65 study sites to determine the relative efficacy of the TEE-guided and conventional approaches to electrical cardioversion for patients in AF. The results of this investigation will have important clinical implications for the management of patients with AF undergoing electrical cardioversion.