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: 6701779
• 负责人: ARTHUR M FELDMAN
• 金额: $ 2.51万
• 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/6701779
• 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）： 缺血性心力衰竭外科治疗（斯蒂奇）多中心 一项国际随机试验解决了两个特定的主要假设， 临床心力衰竭（HF）和左心室（LV）患者 患有冠状动脉疾病（CAD）的功能障碍患者适合手术治疗 血运重建：1）冠状动脉旁路移植术（CABG）， 与单独使用MED相比，药物治疗（MED）可改善长期生存率; 2)在左心室前壁功能障碍患者中， (SVR)更正常的左心室大小可以提高生存率， 与单独进行冠状动脉旁路移植术相比，因心脏原因住院治疗。重要 次要终点包括发病率、经济学和生活质量。核心 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的数据标准化， 确定合格的患者，并解决与 主要假设。 在三年内，50个临床研究中心将招募2，800名同意患者 HF、LV射血分数（EF）<0.35和CAD适合CABG。这些 患者的特征首先是心绞痛强度或左心室的存在。 主冠状动脉狭窄仅适用于手术治疗或 内科或外科治疗。所有患者将接受进一步评估， 收缩末期容积指数（ESVI）>60表明SVR适当 ml/m2，左室前壁运动不能>35%。600名患者估计 有资格接受SVR，但无资格随机接受药物治疗 将平均随机分配至CABG伴或不伴SVR组。在2200人中 同意接受内科或外科治疗的患者中， 将在仅MED和MED联合CABG之间均匀随机分配符合SVR条件的患者。 其余600例也有资格接受SVR的患者将随机分配至 MED + CABG或MED + CABG + SVR三种治疗。登记处 将保留符合条件的患者的临床信息， 试输入。每四个月一次，至少三年， 将对随机化患者进行临床访视，并对登记研究患者进行随访 将通过电话跟踪。随机化患者的适当亚组 将在指定的随访时间间隔重复进行核心实验室研究。 在随机接受MED联合或不联合CABG的患者中， 假设证明全因主要终点降低>20% 预测的25%的3年死亡率中， MED.在SVR合格患者中，假设CABG + SVR显示20% 无住院生存终点的优势和90%把握度 对于心脏原因，预计在接受以下治疗的患者中， 无SVR的CABG。潜在疗法的疗效定义及其 斯蒂奇试验的获益机制肯定会为未来的选择提供信息， 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HF的患者。