OCCLUDED ARTERY TRIAL--CLINICAL COORDINATING CENTER

动脉闭塞试验--临床协调中心

• 批准号: 6527429
• 负责人: Judith S Hochman
• 金额: $ 75.69万
• 依托单位: ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS
• 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 2003-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6527429
• 关键词: ACE inhibitors; artery occlusion; aspirin; beta adrenergic agent; blood vessel prosthesis; cardiovascular disorder epidemiology; clinical research; combination therapy; cooperative study; health care cost /financing; heart disorder chemotherapy; human subject; human therapy evaluation; intraluminal angioplasty; myocardial infarction; quality of life; reperfusion

Background. The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacological strategies fail to achieve effective reperfusion in 30% or more of patients, and many patients with occluded infarct arteries 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 US acute MI patients. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12-24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis: The central hypothesis of the Open Artery Trial is that opening an occluded infarct artery 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50% or proximal occlusion of a large coronary artery) will reduce the composite endpoint of mortality, recurrent MI, and hospitalization for NYHA class IV congestive hear failure (CHF) over an average three year follow-up. Specific aims. The study will be a prospective clinical trial with 3,200 patients randomly allocated in equal proportions to two tretments arms 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. Clinical outcomes will be compared using an intention-to-treat analysis. We have one primary specific aim: 1) To compare the composite outcome of all-cause mortality, non-fetal MI and hospitalization of NYHA class IV CHF based on an average three year follow-up among patients assigned to the two treatments. We have three secondary specific aims: 1) To compare the individual components of the study composite primary endpoint in the two treatment arms. 2) To compare the medical costs of the two treatments and assess the cost effectiveness of percutaneous revascularization in the study population. 3) To compare health-related quality of life in the two treatment groups. Operations. The Luke's-Roosevelt Hospital in New York City. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute. The Economics and Quality of Life Coordinating Center is at Duke University. The Angiographic Core Laboratory is at the University of British Columbia.

背景。 现在已经确立了在急性心肌梗塞（MI）中建立早期冠状动脉再灌注的好处。但是，当前的药理学策略无法在30％或更多的患者中实现有效再灌注，许多锁骨梗塞动脉的患者不符合当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，可用于一小部分潜在的符合条件的美国急性MI患者。 因此，大量的急性MI患者经过了持续闭合的梗塞容器，再灌注疗法具有任何有记录的益处（12-24小时）的时间。 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：开放动脉试验的中心假设是，在高危病人的急性MI急性MI后3-21天开放一个闭塞的梗塞动脉（射血分数小于50％或大型冠状动脉的近端闭塞）将减少死亡率的复合终点，而经过nyhha的综合后续范围，以及CHAND HOILDIND FARCONIVE（CHEF）cANCESTIVE and HAINDIVE ANYHA ANY HAN IV）IV iiV（CHAR）IV）IV（CHART）IV ii iv）IV。具体目标。 这项研究将是一项前瞻性临床试验，在两年内，有3200名随机分配给两个tret臂的患者。 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。 将使用意向性治疗分析比较临床结果。 我们有一个主要的特定目的：1）根据分配给两种治疗的患者的平均三年随访，比较全因死亡率，非竞争MI和NYHA IV类CHF的综合结果。 我们有三个次要特定目的：1）比较两个治疗组中研究复合主要终点的各个组成部分。 2）比较两种治疗方法的医疗费用，并评估研究人群经皮血运重建的成本效益。 3）比较两个治疗组中与健康相关的生活质量。 运营。纽约市的卢克 - 罗斯福医院。 数据协调中心（DCC）位于马里兰州医学研究所。 生活协调中心的经济学和质量在杜克大学。 血管造影核心实验室位于不列颠哥伦比亚大学。