Myocardial Viability and Remodeling in the OAT

OAT 中的心肌活力和重塑

• 批准号: 6843144
• 负责人: JAMES E UDELSON
• 金额: $ 54.07万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-01-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6843144
• 关键词: artery; cardiovascular disorder prevention; clinical research; heart circulation; heart revascularization; human subject; longitudinal human study; myocardial infarction; myocardium; relapse /recurrence; single photon emission computed tomography

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 正在进行的NHLBI资助的阻塞动脉试验（OAT）旨在测试以下假设：在MI之后3-28天打开闭塞性梗死相关动脉（IRA），将降低死亡率，经常性MI和NYHA类IV心力衰竭的复合终点。 OAT目前已在24个国家的240个中心随机将大约1100名患者随机分配。 在提议解释晚期血运重建的益处的机制中，由于血液流动到可行的心肌的恢复而导致LV重塑的衰减是最合理的。 我们建议对燕麦的辅助研究，以评估心肌生存能力对LV重塑后MI的影响，并探索梗塞区的保留生存能力，LV重塑的保留可生存力与燕麦干预的反应，IRA后期PCI。 为此，我们建议在燕麦辅助研究（OAT-NUC）中招募200名患者进行可行性和重塑。 这项研究的主要特定目的是1）检验以下假设：与表现为主要梗塞的患者相比，与表现出主要梗塞的患者相比，证明梗塞区域内生存能力的患者的进行性重塑率更少，而2）检验假说，保存的假设是，保留生存能力会改变与后期患者的后期calla ami AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI AMI的生存能力。 所有患者将在基线时和1年后的静止门控塞斯塔米比SPECT成像。 在梗塞区内基线生存能力的参数，LV体积变化和功能的串行测量将由Tufts-New England Medical Center的心脏成像核心实验室进行中心评估，Tufts-New England Medical Center是一组具有丰富经验的多中心临床试验中心脏成像数据的小组。 解决假设的主要研究终点是根据定义的梗塞区域内的可行性的保留程度，将是LV末端 - 舒适体积的串行变化。样本量计算基于同一组从相似数量的临床部位研究的患者评估的数据。 因此，样本量预测是强大的，适合当前试验，并且调查小组具有高质量进行拟议的研究的经验。 燕麦-NUC是燕麦的唯一生存力辅助研究，因此在评估燕麦发现的潜在机制方面非常需要。