DECIPHER STICH

破译史蒂奇

• 批准号: 6560229
• 负责人: JULIO PANZA
• 金额: $ 59.5万
• 依托单位: MEDSTAR HEALTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6560229
• 关键词: cardiovascular disorder therapy; clinical research; clinical trial phase III; coronary bypass; diagnosis design /evaluation; dobutamine; echocardiography; heart failure; heart function; human subject; human therapy evaluation; myocardial ischemia /hypoxia; outcomes research; patient oriented research; postoperative state; prognosis

DESCRIPTION (provided by applicant): The Dobutamine Echocardiography in Patients with Ischemic Heart failure Evaluated for Revascularization Study, as part of the Surgical Treatment for Ischemic Heart Failure Trial (DECIPHER-STICH), is designed to address the hypothesis that assessment of myocardial viability with dobutamine echocardiography (DE) in patients with coronary artery disease (CAD), left ventricular (LV) dysfunction and heart failure (HF) identifies the patients who derive the greatest survival benefit from surgical revascularization over medical therapy. In addition, this study will determine the value of DE for the prediction of recovery of LV function following revascularization, the clinical value of DE relative to that of radionuclide techniques used for the same purpose, and the relationship between abnormal LV size and shape and the contractile reserve of dysfunctional myocardium. The overall objective is to define the role of the assessment of myocardial viability with DE in the clinical evaluation and selection of the best treatment modality for this high-risk subset of patients with CAD. DECIPHER-STICH is proposed as an ancillary study to the large-scale STICH trial, a multicenter international randomized study designed to define the role of coronary artery bypass grafting (CABG) and surgical ventricular restoration (SVR) in the treatment of HF in patients with CAD and LV dysfunction. In previous studies, DE has compared favorably to other methods for the detection of viable Myocardium. The widespread availability of echocardiography and the possibility of simultaneously deriving information about structural abnormalities (e.g., thrombi), valve function, and intracardiac pressures in addition to the real-time assessment of regional and global systolic function make DE particularly useful for the comprehensive evaluation of CAD patients with LV dysfunction. Because patients in the STICH trial will also undergo radionuclide tests, the DECIPHER-STICH study will allow a comparison of the most commonly used techniques for assessment of myocardial viability. Patients recruited into the STICH trial will be invited to participate in the DECIPHER-STICH study and asked to sign a separate consent form prior to the randomized assignment of therapy. Forty centers from North America and Europe recruiting patients into the STICH trial have agreed to take part in the DECIPHER-STICH study. A total of 1,450 of the 2,800 patients enrolled into the STICH trial will undergo DE prior to treatment. DECIPHER-STICH will address the hypothesis of greater beneficial effect of CABG over medical therapy alone on 3-year survival rate with 80% power to detect a 25%-to-12.5% reduction in all-cause mortality in patients with viable myocardium. In addition, the study will have >99% power to address three important secondary hypotheses. The results of this study will provide definitive information regarding the value of assessing myocardial viability with DE and significant clinical implications for the selection of patients with CAD, LV dysfunction, and HF who are most likely to benefit from surgical revascularization.

描述（由申请人提供）： 缺血性心力衰竭患者的多巴酚丁胺超声心动图评估 血运重建研究是缺血性心力衰竭手术治疗试验 (DECIPHER-STICH) 的一部分，旨在解决以下假设：通过多巴酚丁胺超声心动图 (DE) 评估冠状动脉疾病 (CAD)、左心室 (LV) 功能障碍和心力衰竭 (HF) 患者的心肌活力，以确定从手术中获得最大生存获益的患者 血运重建优于药物治疗。此外，本研究将确定 DE 对于预测血运重建后左室功能恢复的价值、DE 相对于用于相同目的的放射性核素技术的临床价值，以及左室大小和形状异常与功能障碍心肌的收缩储备之间的关系。总体目标是明确 DE 心肌活力评估在临床评估和选择针对这一高危 CAD 患者亚群的最佳治疗方式中的作用。 DECIPHER-STICH 被提议作为大规模 STICH 试验的辅助研究，这是一项多中心国际随机研究，旨在确定冠状动脉旁路移植术 (CABG) 和心室修复手术 (SVR) 在治疗 CAD 和左心室功能障碍患者的心力衰竭中的作用。 在之前的研究中，DE 与其他检测活菌的方法相比具有优势。 心肌。超声心动图的广泛应用以及除了实时评估局部和整体收缩功能之外还可以同时获取结构异常（例如血栓）、瓣膜功能和心内压信息的可能性，使得 DE 对于左心室功能障碍的 CAD 患者的综合评估特别有用。由于 STICH 试验中的患者还将接受放射性核素测试，因此 DECIPHER-STICH 研究将允许比较最常用的心肌活力评估技术。 招募参加 STICH 试验的患者将被邀请参加 DECIPHER-STICH 研究，并要求在随机分配治疗之前签署单独的同意书。来自北美和欧洲的 40 个招募患者参加 STICH 试验的中心已同意参加 DECIPHER-STICH 研究。参加 STICH 试验的 2,800 名患者中，共有 1,450 名患者将在治疗前接受 DE 治疗。 DECIPHER-STICH 将解决 CABG 比单纯药物治疗对 3 年生存率有更大有益效果的假设，并有 80% 的功效检测到存活心肌患者的全因死亡率降低 25% 至 12.5%。此外，该研究将有 >99% 的功效来解决三个重要的次要假设。这项研究的结果将提供关于用 DE 评估心肌活力的价值的明确信息，以及对选择最有可能从手术血运重建中受益的 CAD、左心室功能障碍和心力衰竭患者的重要临床意义。