OCCLUDED ARTERY TRIAL DATA COORDINATING CENTER

闭塞动脉试验数据协调中心

• 批准号: 6641152
• 负责人: BRUCE BARTON
• 金额: $ 59.79万
• 依托单位: MARYLAND MEDICAL RESEARCH INSTITUTE, INC
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6641152
• 关键词: ACE inhibitors; artery occlusion; aspirin; beta antiadrenergic agent; blood vessel prosthesis; cardiovascular disorder epidemiology; clinical research; clinical trials; combination therapy; congestive heart failure; cooperative study; data management; experimental designs; health behavior; health care cost /financing; heart disorder chemotherapy; human data; human therapy evaluation; intraluminal angioplasty; myocardial infarction; statistical service /center

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.

当前的药理策略无法在30％或更多的急性心肌梗塞（MI）患者中实现有效再灌注，许多患有闭塞性梗塞相关动脉（IRA）的患者不符合当前使用这些药物的标准。 早期的血管成形术是一种有效的再灌注方法，可用于美国的一小部分潜在符合条件的急性MI患者，因此，大量急性MI患者经过了持续关闭IRA的急性疗法（12-24小时）的良好文献记载的益处（12-24小时）。实验和临床证据的几条线表明，这些患者的晚期再灌注可以提供死亡率和发病率的临床显着降低。 假设。在高危患者急性MI后3-21天打开闭塞IRA（射血分数小于50％或大型冠状动脉的近端闭塞）将降低死亡率的复合终点，经常性MI和NYHA类IV级IV级心力衰竭（CHF）的住院时间（CHF）。研究目的。在开放式动脉试验（OAT）中，将在两年内以相等比例地随机分配3200例患者。 一种治疗方法将包括常规医疗管理（包括阿司匹林，β受体阻滞剂，ACE抑制剂和风险因素修饰）。 实验治疗将包括常规医疗疗法以及经皮冠状动脉介入和冠状动脉支架。 主要目的是根据分配给两种治疗的患者的平均3年随访，比较IV类CHF的全因死亡率，非致命MI和住院的综合结果。 三个次要特定目的是比较：1）两种处理中研究的单个组成部分； 2）两种治疗的医疗费用； 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。 该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负责统计设计和功率计算，随机治疗分配，数据管理，对死亡率和发病率分类委员会的支持，快速沟通和生成绩效数据，以与研究主席和临床协调中心的联合主席进行审查以及数据分析，以评估治疗效果。