OCCLUDED ARTERY TRIAL DATA COORDINATING CENTER

目前的药理学策略未能在30%或更多的急性心肌梗死（MI）患者中实现有效的再灌注，并且许多患有闭塞的梗死相关动脉（IRA）的患者不符合目前使用这些药物的标准。 早期血管成形术是一种有效的再灌注方法，在美国只有一小部分潜在的符合条件的急性心肌梗死患者可以使用。S. 因此，大量急性MI患者在再灌注治疗具有充分证明的获益时（12-24小时），IRA持续关闭。一些实验和临床证据表明，这些患者的晚期再灌注可以提供临床上显著的死亡率和发病率降低。 假说.无症状高危患者（射血分数低于50%或大冠状动脉近端闭塞）发生急性心肌梗死后3-21天开放闭塞的伊拉，将减少平均3年随访期间的死亡率、复发性心肌梗死和因NYHA IV级充血性心力衰竭（CHF）住院治疗的复合终点。研究目的。在开放动脉试验（OAT）中，3，200名患者将在两年内以相等比例随机分配至两种治疗。 一种治疗将包括常规药物管理（包括阿司匹林、β受体阻滞剂、ACE抑制剂和风险因素调整）。 实验治疗将包括常规药物治疗加经皮冠状动脉介入治疗和冠状动脉支架植入术。 主要具体目的是基于分配至两种治疗的患者的平均3年随访，比较全因死亡率、非致死性MI和IV级CHF住院治疗的复合结局。 三个次要具体目标是比较：1）两种治疗中研究复合主要终点的单个组成部分; 2）两种治疗的医疗成本; 3）两种治疗中与健康相关的生活质量。数据协调中心的作用。 本申请是为了支持马里兰州医学研究所的数据协调中心（DCC）。 DCC负责统计设计和把握度计算、随机治疗分配、数据管理、支持死亡率和死亡率分类委员会、快速沟通和生成性能数据以供临床协调中心的研究主席和联合主席审查，并进行数据分析以评估治疗效果。

Current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of acute myocardial infarction (MI) patients, and many patients with occluded infarct-related arteries (IRAs) do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible acute MI patients in the U. S. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has well documented benefit (12-24 hours) with a persistently closed IRAs. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis. Opening an occluded IRA 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50 percent or proximal occlusion of a large coronary artery) will reduce the composite end point of mortality, recurrent MI, and hospitalization for NYHA Class IV congestive heart failure (CHF) over an average 3-year follow-up. Study aims. In the Open Artery Trial (OAT) 3,200 patients will be randomly allocated in equal proportions to the two treatments over two years. One treatment will consist of conventional medical management (including aspirin, beta blockers, ACE inhibitors, and risk factor modification). The experimental treatment will consist of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. The primary specific aim is to compare the composite outcome of all-cause mortality, non-fatal MI and hospitalization for Class IV CHF based on an average 3-year follow-up among patients assigned to the two treatments. Three secondary specific aims are to compare: 1) the individual components of the study composite primary end point in the two treatments; 2) the medical costs of the two treatments; and 3) health-related quality of life in the two treatments. Role of Data Coordinating Center. This application is made for support of a Data Coordinating Center (DCC) at the Maryland Medical Research Institute. The DCC is responsible for statistical design and power calculations, random treatment assignments, data management, support for the Mortality and Morbidity Classification Committee, rapid communication and generation of performance data for review with the Study Chair and Co-Chair of the Clinical Coordinating Center and data analysis to assess treatment effects.