STICH-Trial Cardiovascular Magenetic Resonance Core Lab

STICH-试用心血管磁共振核心实验室

• 批准号: 7046019
• 负责人: GERALD Michael POHOST
• 金额: $ 22.93万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2007-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7046019
• 关键词: bioimaging /biomedical imaging; biomedical facility; computer assisted diagnosis; cooperative study; coronary bypass; diagnosis quality /standard; heart dimension /size; heart disorder chemotherapy; heart disorder diagnosis; heart failure; heart imaging /visualization /scanning; heart revascularization; human subject; human therapy evaluation; image processing; magnetic resonance imaging; myocardial ischemia /hypoxia; noninvasive diagnosis; patient oriented 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) 多中心手术治疗 国际随机试验解决了两个具体的主要假设 患有临床心力衰竭 (HF) 和左心室 (LV) 的患者 患有冠状动脉疾病（CAD）且适合手术治疗的功能障碍患者 血运重建： 1) 强化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； 2) 对于左室前功能障碍的患者，进行心室修复手术 (SVR) 至更正常的 LV 大小可提高生存率，而无需后续治疗 与单纯冠状动脉搭桥术相比，因心脏病原因住院的情况。重要的 次要终点包括发病率、经济状况和生活质量。核 心脏磁共振 (CMR)、超声心动图 (ECHO) 实验室、 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 确定符合条件的患者并解决与患者相关的具体问题 主要假设。 三年内，50 个临床中心将招募 2,800 名同意的患者 心力衰竭、左心室射血分数 (EF) <.35 且 CAD 适合 CABG。这些 患者首先会以心绞痛强度或左心绞痛的存在为特征 主要冠状动脉狭窄仅适合手术治疗或 药物或手术治疗。所有患者都将接受进一步评估 收缩末期容积指数 (ESVI) >60 表明 SVR 的适当性 ml/m2 和左心室前壁运动不能>35%。估计有 600 名患者 有资格获得 SVR 但没有资格随机接受药物治疗 将被均匀随机分配至有或没有 SVR 的 CABG。在 2,200 人中 同意接受药物或手术治疗的患者，这 1,600 名患者没有资格 符合 SVR 资格的人将在仅 MED 和 MED 联合 CABG 之间均匀随机分配。 其余 600 名也符合 SVR 条件的患者将被随机分配 仅 MED 或 MED + CABG 或 MED + CABG + SVR 的三种治疗方法。登记处 将保留符合条件的拒绝接受治疗的患者的临床信息 试用进入。至少三年内，每隔四个月，所有 随机分组的患者将接受临床访问和登记患者 随后将通过电话。随机分组患者的适当亚组 将按照指定的后续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，CABG 联合 MED 假设证明全因主要终点减少>20% 预计三年死亡率为 25%，死亡率为 89% 医学。在符合 SVR 资格的患者中，假设 CABG + SVR 的比例为 20% 在免住院生存终点方面具有 90% 功效的优势 在接受治疗的患者中，三年内因心脏病原因预计为 50% 无需 SVR 的 CABG。潜在疗法功效的定义及其效果 STICH 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 现在患有缺血性心力衰竭的患者。