The American journal of cardiology
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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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Controversy exists as to the clinical roles and relative specificities of cardiac troponin T or I in patients with unstable angina pectoris (UAP). We measured troponin T and I levels on admission in 123 patients with UAP. Of the 107 patients with normal creatine kinase during the first 24 hours, troponin T and I were elevated in 14 and 13 patients, respectively. ⋯ Comparison of the sensitivities and specificities of both markers using summary receiver operating characteristic curves showed no significant difference in their abilities to predict acute myocardial infarction and cardiac death. Troponin T and I show similar prognostic significance for acute myocardial infarction or death in the same patients with UAP. The 2 markers are equally sensitive and specific, as confirmed by meta-analysis, and this supports a role in risk stratification.
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Biography Historical Article
William Howard Frishman, MD: a conversation with the editor. Interview by William Clifford Roberts.
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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.