STICH-Trial Cardiovascular Magenetic Resonance Core Lab

描述(由申请人提供)： 多中心缺血性心力衰竭的外科治疗 国际随机试验解决了两个具体的主要假设 临床心力衰竭(HF)和左心室(LV)患者 患有冠状动脉疾病(CAD)的功能障碍者可接受手术 血运重建：1)冠状动脉旁路移植(CABG) 与单独使用药物治疗(MED)相比，药物治疗(MED)可提高长期存活率； 2)对左前壁功能不全的患者，行外科心脏重建术 (SVR)至更正常的LV大小可提高存活率，不受后续 与单纯冠状动脉搭桥术相比，因心脏原因住院。重要 次要终点包括发病率、经济和生活质量。堆芯 心脏磁共振(CMR)、超声心动图(ECHO)、 神经激素/细胞因子/遗传(NCG)和放射性核素(RN)研究将 确保一致的测试实践和必要数据的标准化 确定符合条件的患者并解决与 主要假设。 在三年内，50个临床站点将招募2800名同意的患者 心衰、左心室射血分数(EF)和冠状动脉旁路移植术(CABG)。这些 首先，患者的特征是心绞痛强度或存在左 仅适用于外科治疗的主要冠状动脉狭窄或 内科或外科治疗。所有患者都将接受进一步的评估 用收缩末期容量指数(ESVI)指示SVR的适宜性 M l/m~2，运动迟缓占左前壁的35%。据估计，600名患者 有资格接受SVR，但没有资格随机接受药物治疗 将随机分为冠脉搭桥术组和非冠脉搭桥组。在2200人中 1,600名有资格接受内科或手术治疗的患者 符合条件的SVR将在仅MED和MED加CABG之间均匀随机分配。 其余600名也有资格接受SVR的患者将随机分配到 单纯MED、MED+CABG、MED+CABG+SVR三种治疗方法。注册处 将保留符合条件的拒绝接受治疗的患者的临床信息 试用入门。每隔四个月至少三年，所有 随机化的患者之后将进行临床访问和登记患者 接下来的是电话。随机化患者的适当分组 将在指定的后续时间间隔内重复进行核心实验室研究。 在随机选择接受或不接受冠状动脉搭桥术的MED患者中，CABG合并MED的患者 假设将所有原因的主要终点减少20% 预计三年死亡率为25%，死亡率为89% 地中海医院。在符合SVR条件的患者中，CABG+SVR假设显示20% 在免住院生存终点90%功率的优势 在接受治疗的患者中，三年后心脏原因预计为50% 冠状动脉旁路移植术(CABG)不含SVR。潜在疗法及其疗效的定义 STICH试验的受益机制肯定会为未来选择 治疗，从而延长和改善数百万人的生活质量 现在患有缺血性心力衰竭的患者。

DESCRIPTION (provided by applicant): The Surgical Treatment for Ischemic Heart Failure (STICH) multicenter international randomized trial addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease (CAD) amenable to surgical revascularization: 1) Coronary artery bypass grafting (CABG) with intensive medical therapy (MED) improves long-term survival compared to MED alone; 2) In patients with anterior LV dysfunction, surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause in comparison to CABG alone. Important secondary endpoints include morbidity, economics, and quality of life. Core laboratories for cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/ cytokine/genetic (NCG), and radionuclide (RN) studies will ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the primary hypotheses. Over three years, 50 clinical sites will recruit 2,800 consenting patients with HF, LV ejection fraction (EF) <.35, and CAD amenable to CABG. These patients first will be characterized by angina intensity or presence of left main coronary stenosis as appropriate for only surgical therapy or either medical or surgical therapy. All patients will be evaluated further for appropriateness of SVR indicated by an end-systolic volume index (ESVI) >60 ml/m2 and akinesia >35% of the anterior LV wall. The 600 patients estimated to be eligible for SVR but ineligible for randomization to medical therapy will be evenly randomized to CABG with or without SVR. Of the 2,200 consenting patients eligible for medical or surgical therapy, the 1,600 not SVR eligible will be evenly randomized between MED only and MED with CABG. The remaining 600 patients also eligible for SVR will be randomized between three treatments of MED only, or MED + CABG, or MED + CABG + SVR. Registries of clinical information will be maintained on eligible patients who decline trial entry. At four-month intervals for a minimum of three years, all randomized patients will be followed by a clinical visit and registry patients will be followed by telephone. Appropriate subgroups of randomized patients will have core laboratory studies repeated at specified follow-up intervals. In the patients randomized to MED with or without CABG, CABG with MED is hypothesized to demonstrate a >20% reduction in the primary endpoint of all-cause death with an 89% power from the projected 25% three-year mortality for MED. In the SVR-eligible patients, CABG + SVR is hypothesized to show a 20% advantage with 90% power in the endpoint of survival free of hospitalization for cardiac cause projected to be 50% at three years in patients receiving CABG without SVR. Definition of efficacy of potential therapies and their mechanisms of benefit by the STICH Trial is certain to inform future choice of therapy and thereby extend and improve the quality of lives of millions of patients who now suffer from ischemic HF.