Electrophysiologic effects of late PCI (OAT-EP)

晚期 PCI 的电生理效应 (OAT-EP)

• 批准号: 6599541
• 负责人: ERIC J RASHBA
• 金额: $ 32.83万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6599541
• 关键词: arrhythmia; artery occlusion; blood vessel prosthesis; clinical research; electrocardiography; heart electrical activity; heart rate; human subject; intraluminal angioplasty; myocardial infarction; patient oriented research; prognosis

DESCRIPTION (provided by applicant): There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among patients who present with acute myocardial infarction (AMI). The mechanism of the benefit of early reperfusion (< 6 hours after AMI onset) was initially attributed to myocardial salvage and the resultant preservation of left ventricular function. However, it is now evident that the survival benefit associated with thrombolytic therapy is not consistently associated with a major improvement in left ventricular ejection fraction (LVEF). These observations led to the formulation of the "late open artery hypothesis", which posits that clinical outcomes can potentially be improved by late reperfusion after AMI. Observational clinical studies have suggested that late patency of the infarct-related artery (IRA) after thrombolysis is associated with a survival benefit that is independent of LVEF and therefore cannot be solely explained by salvage of myocardium. Definitive proof of the late open artery hypothesis is currently lacking, however, because previous prospective studies that have evaluated late percutaneous transluminal coronary angioplasty (PTCA) of occluded IRAs after AMI have produced conflicting results. These considerations led to the organization of the Occluded Artery Trial (OAT), an international, NHLBI-funded randomized trial of 3,200 patients that is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and stenting (PCI) 3-28 days after AMI in high risk patients will reduce a composite endpoint of mortality, recurrent MI, and hospitalization for class IV congestive heart failure. Enhancement of electrical stability is one of the major mechanisms that have been proposed to explain the association of an open IRA with an improved prognosis independent of myocardial salvage. The present OAT-EP ancillary study application will characterize the effects of late PCI of occluded IRAs on the most prognostically important and clinically relevant noninvasive markers of vulnerability to malignant ventricular arrhythmias: heart rate variability, T wave variability, and signal-averaged electrocardiography. These analyses will be performed in 300 patients at baseline, 30 days and one year following MI in order to delineate the effects of late PCI on the autonomic nervous system, ventricular repolarization, and ventricular conduction abnormalities, respectively.

描述（由申请人提供）： 现在有明确的证据表明，使用血栓溶液或原发性血管成形术的早期冠状动脉再灌注会导致出现急性心肌梗塞（AMI）的患者长期死亡率降低。 早期再灌注的好处（AMI发作后<6小时）的机制最初归因于心肌挽救，并保留左心室功能。 但是，现在很明显，与溶栓疗法相关的生存益处与左心室射血分数（LVEF）的重大改善不一致。 这些观察结果导致了“晚期开放动脉假说”的制定，该假设认为临床结果可以通过AMI后的晚期再灌注来改善。 观察性临床研究表明，溶栓后与梗死相关的动脉（IRA）的晚期通畅与独立于LVEF的生存益处相关，因此不能完全通过心肌的拯救来解释。 然而，目前缺乏确定性开放动脉假说的确定性证明，因为AMI后，AMI闭塞IRA的先前的前瞻性研究已经评估了经皮易流性冠状动脉血管成形术（PTCA）。 These considerations led to the organization of the Occluded Artery Trial (OAT), an international, NHLBI-funded randomized trial of 3,200 patients that is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and stenting (PCI) 3-28 days after AMI in high risk patients will reduce a composite endpoint of mortality, recurrent MI, and hospitalization for class IV congestive heart failure. 电稳定性的增强是提出的主要机制之一，以解释开放IRA与无关心肌挽救的预后改善的关联。目前的OAT-EP辅助研究应用程序将表征闭塞IRA的晚期PCI对最重要和临床上相关的无创标志物的影响，这些标志物具有恶性心律失常的脆弱性：心脏变异性，T波变异性，T波变异性和信号感受心动管造影。 这些分析将在基线时，30天和MI之后的300例患者中进行，以描绘晚期PCI对自主神经系统，心室复极化和心室传导异常的影响。