Myocardial Viability and Remodeling in the OAT

正在进行的NHLBI资助的闭塞动脉试验(OAT)旨在测试以下假设： 心肌梗死后3-28天闭塞的脑梗塞相关动脉(IRA)将减少 三年随访的死亡率、复发心肌梗死和NYHA IV级心力衰竭。燕麦片目前已经 对24个国家的240个中心的约1100名患者进行了随机调查。在建议的机制中 解释晚期血管重建术的益处，左心功能的恢复和左室重构的减弱 恢复存活心肌的血流量是最有可能的。我们建议对燕麦片进行辅助研究 评价存活心肌对心肌梗死后左室重构的影响，并探讨两者的关系。 晚期梗死区存活率、左室重构与燕麦片干预反应之间的关系 爱尔兰共和军的PCI。为此，我们建议招募200名患者参加OAT的生存和重塑 辅助研究(OAT-NUC)。这项研究的主要具体目的是1)检验患者 谁证明在梗死区内的生存能力的保存将证明不那么进行性的重塑 与表现为主要脑梗塞的患者进行比较，以及2)检验以下假设 生存能力将改变随机化对急性心肌梗死后急性心肌梗死患者晚期血管重建的治疗效果 急性心肌梗死后3-28天闭塞的IRA。所有患者都将接受静息门控~(99m)Tc-Sestamibi SPECT显像 在基线时，一年后再次。梗死区内基线生存能力的参数，以及 心脏成像核心将集中评估左心室容量变化和功能的测量 塔夫茨-新英格兰医学中心的实验室，一个具有丰富心脏分析经验的小组 多中心临床试验中的影像数据。解决这些假设的主要研究终点将是连续的 左心室舒张末容量的变化，基于确定的梗死区内存活能力的保存程度 区域。样本量的计算是基于同一组从相似数量的 患者在类似数量的临床地点进行研究。因此，样本量预测是稳健的，并且 适合目前的审判，调查组有经验执行拟议的 高质量地学习。燕麦-NUC是燕麦片唯一的可行性辅助研究，因此满足了关键需求 在评估审查处调查结果的潜在机制方面。

The ongoing NHLBI-funded Occluded Artery Trial (OAT) is designed to test the hypothesis that opening an occluded infarct related artery (IRA) 3-28 days following an MI will reduce the composite endpoint of mortality, recurrent MI, and NYHA class IV heart failure over three-year follow-up. OAT has currently randomized approximately 1100 patients in 240 centers in 24 countries. Among the mechanisms proposed to explain benefit of late revascularization, recovery of LV function and attenuation of LV remodeling due to restoration of blood flow to viable myocardium is the most plausible. We propose an ancillary study of OAT to assess the effect of myocardial viability on LV remodeling post-MI, and to explore the relationships between retained viability of the infarct zone, LV remodeling, and the response to the OAT intervention, late PCI of the IRA. To this end, we propose to enroll 200 patients in the Viability and Remodeling in OAT Ancillary Study (OAT-NUC). The primary specific aims of this study are 1) to test the hypothesis that patients who demonstrate preservation of viability within the infarct zone will evidence less progressive remodeling compared to patients exhibiting predominant infarct, and 2) to test the hypothesis that preservation of viability will modify the treatment effect of randomization to late revascularization of post-MI patients with an occluded IRA 3-28 days after an AMI. All patients will have resting gated Tc-99m sestamibi SPECT imaging at baseline, and again 1 year later. Parameters of baseline viability within the infarct zone, and serial measures of LV volume change and function will be centrally assessed by the Cardiac Imaging Core Laboratory at Tufts-New England Medical Center, a group with substantial experience analyzing cardiac imaging data in multicenter clinical trials. The major study endpoint to address the hypotheses will be serial change in LV end-diastolic volume, based on the degree of preservation of viability within the defined infarct zone. Sample size calculations are based on data evaluated by the same group from a similar number of patients studied at a similar number of clinical sites. Hence, sample size projections are robust and appropriate for the current trial, and the investigative group has the experience to carry out the proposed study with high quality. OAT-NUC is the only viability ancillary study of OAT, and thus serves a critical need in assessing potential mechanisms of the findings in OAT.