DECIPHER STICH

破译史蒂奇

• 批准号: 7046013
• 负责人: JULIO PANZA
• 金额: $ 10.69万
• 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 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7046013
• 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）： 多巴酚丁胺超声心动图对缺血性心力衰竭的评价 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：在患有冠状动脉疾病（CAD）、左心室（LV）功能障碍和心力衰竭（HF）的患者中，使用多巴酚丁胺超声心动图（DE）评估心肌活力，确定手术血运重建比药物治疗获得最大生存获益的患者。此外，本研究还将确定DE在预测血运重建后左室功能恢复方面的价值，DE相对于用于相同目的的放射性核素技术的临床价值，以及异常左室大小和形状与功能障碍心肌的收缩储备之间的关系。总体目标是确定DE心肌活力评估在临床评价中的作用，并为该高风险CAD患者子集选择最佳治疗方式。DECIPHER-斯蒂奇拟作为大规模斯蒂奇试验的辅助研究，该试验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）和手术心室修复术（SVR）在CAD和LV功能障碍患者HF治疗中的作用。 在以前的研究中，DE与其他方法相比， 肌肉男超声心动图的广泛可用性和同时获得关于结构异常的信息的可能性（例如，除了实时评估局部和整体收缩功能外，DE还可用于评估血栓）、瓣膜功能和心内压力，这使得DE特别适用于综合评估伴有LV功能障碍的CAD患者。由于斯蒂奇试验中的患者也将接受放射性核素检查，因此DECIPHER-斯蒂奇研究将允许比较最常用的心肌活力评估技术。 将邀请入组斯蒂奇试验的患者参加DECIPHER-斯蒂奇研究，并要求其在随机分配治疗前签署单独的知情同意书。来自北美和欧洲的40家中心招募患者参加斯蒂奇试验，并同意参加DECIPHER-斯蒂奇研究。斯蒂奇试验入组的2,800例患者中，共有1,450例将在治疗前接受DE。DECIPHER-STICH将解决这样的假设：冠状动脉旁路移植术比单独药物治疗对3年生存率的有益影响更大，有80%的把握度检测到有存活心肌的患者的全因死亡率降低25%至12.5%。此外，该研究将有>99%的把握度来解决三个重要的次要假设。本研究的结果将提供关于DE评估心肌存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获益的CAD、LV功能障碍和HF患者的重要临床意义。