OCCLUDED ARTERY TRIAL DATA COORDINATING CENTER

闭塞动脉试验数据协调中心

• 批准号: 6390335
• 负责人: Genell L Knatterud
• 金额: $ 70.81万
• 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 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6390335
• 关键词: ACE inhibitors; artery occlusion; aspirin; beta antiadrenergic agent; blood vessel prosthesis; cardiovascular disorder epidemiology; clinical research; 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.

目前的药物治疗策略未能在30%或更多的急性心肌梗死(MI)患者中实现有效的再通，许多闭塞的梗塞相关动脉(IRA)患者不符合目前使用这些药物的标准。在美国，早期血管成形术是一种有效的再通方法，只适用于一小部分潜在合格的急性心肌梗死患者。因此，相当数量的急性心肌梗死患者在IRAS持续关闭的情况下，通过再灌注治疗有充分证据证明有好处(12-24小时)。一些实验和临床证据表明，这些患者的晚期再灌注可以在临床上显著降低死亡率和发病率。假设。对于无症状的高危患者(射血分数低于50%或大冠状动脉近端闭塞)，在急性心肌梗死后3-21天开放闭塞的IRA将在平均3年的随访中减少NYHA IV级充血性心力衰竭(CHF)的死亡率、复发心肌梗死和住院治疗的综合终点。研究目的。在开放动脉试验(OAT)中，3200名患者将在两年内被随机等比例分配到两种治疗方法中。一种治疗将包括传统的医疗管理(包括阿司匹林、β受体阻滞剂、血管紧张素转换酶抑制剂和风险因素修改)。试验性治疗将包括常规药物治疗加上经皮冠状动脉介入治疗和冠状动脉支架置入术。主要的具体目标是比较所有原因死亡率、非致命性心肌梗死和住院治疗IV级充血性心力衰竭患者的综合结果，这些结果是基于被分配到这两种治疗方法的患者平均3年的随访。三个次要的具体目标是比较：1)两种治疗方法中研究的各个组成部分综合主要终点；2)两种治疗方法的医疗费用；以及3)两种治疗方法中与健康相关的生活质量。数据协调中心的作用。此申请是为了支持马里兰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供临床协调中心研究主席和联合主席审查，以及进行数据分析以评估治疗效果。