The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Randomized antiarrhythmic drug therapy in survivors of cardiac arrest (the CASCADE Study). The CASCADE Investigators.
The Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) study evaluated antiarrhythmic drug treatment of survivors of out-of-hospital ventricular fibrillation (VF) not associated with a Q-wave myocardial infarction who were at especially high risk of recurrence of VF. Therapy was randomized to empiric treatment with amiodarone versus treatment with other antiarrhythmic drugs guided by electrophysiologic testing, Holter recording, or both (conventional therapy). The primary end points of the study were cardiac mortality, resuscitated cardiac arrest due to documented VF, or complete syncope followed by a shock from an implanted automatic defibrillator. ⋯ Mean left ventricular ejection fraction was 0.35, and 102 patients (45%) had a prior history of congestive heart failure. Survival free of cardiac death, resuscitated VF, or syncopal defibrillator shock for the entire population was 75% at 2 years (amiodarone, 82%; conventional, 69%), 59% at 4 years (amiodarone, 66%; conventional, 52%), and 46% at 6 years (amiodarone, 53%; conventional, 40%); p = 0.007. The survival free of cardiac death and sustained ventricular arrhythmias was 65% at 2 years (amiodarone, 78%; conventional, 52%), 43% at 4 years (amiodarone, 52%; conventional, 36%), and 30% at 6 years (amiodarone, 41%; conventional, 20%); p < 0.001.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Rationale and design of the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial (HIT) for secondary prevention of coronary artery disease in men with low high-density lipoprotein cholesterol and desirable low-density lipoprotein cholesterol.
Although a large body of epidemiologic evidence suggests that low levels of high-density lipoprotein (HDL) cholesterol are strongly associated with an increased risk of coronary artery disease (CAD), no large-scale clinical trials focusing on this association have been reported. This report describes the rationale and design of the Department of Veterans Affairs HDL Intervention Trial (HIT), a multicenter, randomized, controlled clinical trial designed to determine whether lipid therapy reduces the combined incidence of CAD death and nonfatal myocardial infarction in men with established CAD who have low levels of HDL cholesterol with "desirable" levels of low-density lipoprotein (LDL) cholesterol. ⋯ In this population, gemfibrozil is expected to increase HDL cholesterol by 10 to 15%, have a negligible effect on LDL cholesterol, and lower triglycerides by 30 to 40%. Because an estimated 20 to 30% of patients with CAD have a low HDL cholesterol as their primary lipid abnormality, the results of this trial are expected to have far-reaching clinical implications.
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Multicenter Study Clinical Trial
Long-term safety and efficacy of flecainide in the treatment of supraventricular tachyarrhythmias: the United States experience. The Flecainide Supraventricular Tachyarrhythmia Investigators.
Information about long-term safety and effectiveness is important for appropriate use of antiarrhythmic drug therapy. We report the results of an open-label, long-term (mean, 15 months) therapy extension for 66 patients with paroxysmal supraventricular tachycardia (PSVT) or atrial fibrillation (PAF) in whom short-term therapy in 2 controlled studies was deemed beneficial by both patient and investigator. Follow-up was accomplished by clinic visits and telephone calls. ⋯ No clinically significant laboratory, electrocardiographic, or physical abnormalities were ascribed to flecainide. Thus, the long-term safety and efficacy profile of the drug for treatment of PSVT and PAF is encouraging. This promising clinical experience is relatively small and so should be reinforced by larger patient trials in the future.
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Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial
Methodologic issues in clinical evaluation of stenosis severity in adults undergoing aortic or mitral balloon valvuloplasty. The NHLBI Balloon Valvuloplasty Registry.
Although both catheterization and Doppler measures of valvular stenosis severity have been validated, each has specific advantages and limitations, particularly in the setting of balloon valvuloplasty. Invasive valve area and mean pressure gradient recorded immediately before and after aortic (n = 589) or mitral (n = 608) catheter balloon valvuloplasty were compared with Doppler valve area and mean pressure gradient recorded less than 30 days before and 24 to 72 hours after the procedure. For aortic stenosis, Doppler valve area ranged from 0.1 to 1.4 cm2 before and 0.2 to 2.3 cm2 after catheter balloon valvuloplasty. ⋯ Important variables affecting the differences were mitral regurgitation, interatrial shunt, cardiac output and heart rate. Nonsimultaneous studies, differing volume flow measurements, and the underlying accuracy of each technique largely account for discrepancies between these methods. The clinical use of each will depend on its ability to predict long-term patient outcome.
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Multicenter Study Clinical Trial
Clinical characteristics and natural history of survivors of pulmonary congestion during acute myocardial infarction. The Multicenter Postinfarction Research Group.
Although pulmonary congestion during acute myocardial infarction (AMI) is recognized as an important adverse event, the detailed clinical features, natural history and predictive value of standard diagnostic tests in such patients have not been well characterized. As part of a multicenter prospective postinfarction trial, 123 patients with pulmonary congestion during AMI, who survived and were discharged from the coronary care unit, were studied. These patients were compared with similar patients who did not develop pulmonary congestion. ⋯ In patients with pulmonary congestion, ejection fraction (dichotomized at 30%) and exercise testing were the most discriminating tests in risk stratification. An ejection fraction greater than 30% and completion of the exercise test was associated with a 7% mortality while an ejection fraction less than 30% and inability to take or complete the exercise test was associated with a 44% 1-year mortality. A greater incidence of reinfarction, ischemia during exercise and ischemic events at the time of death in the pulmonary congestion group suggests that ischemia may be an important factor in this high risk category.