STICH TRIAL - NEUROHORMONAL/ CYTOKINE/ GENETIC CORE LAB

STICH 试验 - 神经激素/细胞因子/遗传核心实验室

• 批准号: 6869597
• 负责人: ARTHUR M FELDMAN
• 金额: $ 23.39万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6869597
• 关键词: biomedical facility; catecholamines; clinical research; congestive heart failure; cytokine; genetic markers; genetic screening; human subject; neurohormones; outcomes research

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.

描述（由申请人提供）： 缺血性心力衰竭（Stich）多中心的手术治疗 国际随机试验介绍了两个特定的主要假设 临床心力衰竭（HF）和左心室（LV）的患者 患有冠状动脉疾病（CAD）的功能障碍 血运重建：1）冠状动脉搭桥术（CABG） 与单独使用MED相比，医疗疗法（MED）可改善长期生存； 2）在前LV功能障碍的患者中，手术性心室恢复 （SVR）到更正常的LV尺寸可提高生存率 与仅CABG相比，心脏原因的住院治疗。重要的 次要终点包括发病率，经济学和生活质量。核 心脏磁共振的实验室（CMR），超声心动图（ECHO），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所需数据的标准化 确定合格的患者，并解决与 主要假设。 在三年中，有50个临床部位将招募2,800名同意患者 使用HF，LV射血分数（EF）<.35，并且CAD可与CABG合作。这些 患者首先以心绞痛或左的存在为特征 主要的冠状动脉狭窄仅适用于手术疗法或 医学或外科疗法。所有患者将进一步评估 SVR的适当性通过末端音量卷指数（ESVI）> 60表示 ML/M2和Akinesia>前LV壁的35％。 600名患者估计 有资格获得SVR，但没有资格进行医疗治疗 如果有或没有SVR，将均匀地随机与CABG。 2200 同意的患者有资格接受医疗或外科疗法，1,600名不 符合SVR的资格将在MED和MED之间均匀地随机随机。 其余的600名患者也有资格获得SVR 仅MED或MED + CABG或MED + CABG + SVR的三种治疗方法。登记处 临床信息将保留到符合条件的患者的临床信息 试用条目。在至少三年的时间间隔四个月的时间间隔 随机患者将进行临床访问和注册患者 随后将进行电话。随机患者的适当亚组 将在特定的随访间隔中重复进行核心实验室研究。 在随机使用或不带CABG的患者中，带有MED的CABG为 假设在全因的主要终点中证明了> 20％ 预计25％的三年死亡率的死亡人数为89％ 医学在符合SVR资格的患者中，假设CABG + SVR显示为20％ 在没有住院的生存的终点内具有90％功率的优势 对于心脏因果，预计在三年内接受的患者为50％ 没有SVR的CABG。潜在疗法及其功效的定义 Stich试验的受益机制肯定会为未来的选择提供 治疗，从而扩大和改善数百万的生活质量 现在患有缺血性HF的患者。