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 资助的闭塞动脉试验 (OAT) 旨在检验以下假设：在 MI 后 3-28 天打通闭塞的梗塞相关动脉 (IRA) 将降低死亡率、复发性 MI 和 NYHA IV 级心脏的复合终点三年随访失败。 OAT 目前已在 24 个国家的 240 个中心对约 1100 名患者进行了随机分组。 在提出解释晚期血运重建的益处的机制中，由于恢复存活心肌的血流而恢复左心室功能和减弱左心室重构是最合理的。 我们提出了一项 OAT 辅助研究，以评估心肌梗死后心肌活力对 LV 重塑的影响，并探讨梗塞区保留活力、LV 重塑和对 OAT 干预、IRA 晚期 PCI 的反应之间的关系。 为此，我们建议招募 200 名患者参加 OAT 辅助研究 (OAT-NUC) 的生存能力和重塑。 本研究的主要具体目的是 1) 检验这样的假设：与表现出主要梗塞的患者相比，在梗塞区内表现出存活力保留的患者将表现出较少的进行性重塑，2) 检验存活力的保留将改变的假设AMI 后 3-28 天 IRA 闭塞的 MI 后患者随机化至晚期血运重建的治疗效果。 所有患者都将在基线时进行静息门控 Tc-99m 塞他米比 SPECT 成像，并在 1 年后再次进行。 梗塞区内的基线活力参数以及左心室体积变化和功能的系列测量将由塔夫茨-新英格兰医学中心的心脏成像核心实验室进行集中评估，该实验室在多中心临床试验中分析心脏成像数据方面拥有丰富的经验。 解决这些假设的主要研究终点将是左心室舒张末期容积的连续变化，其基于确定的梗塞区域内活力的保存程度。样本量的计算基于同一组在相似数量的临床地点研究的相似数量的患者所评估的数据。 因此，样本量预测是稳健的并且适合当前的试验，并且研究小组具有高质量地开展拟议研究的经验。 OAT-NUC 是 OAT 唯一的可行性辅助研究，因此对于评估 OAT 研究结果的潜在机制至关重要。