CLINICAL COORDINATING CENTER FOR ACIP

本项目的目的是作为试点进行多中心试验 研究，以评估可行性和测试所需的方法， 无症状心肌缺血治疗的全面临床试验。 的 主要目的是确定常规护理的相对功效， 逐步的药物治疗和机械血管重建， 无心肌缺血。 其他目标是确认 目标患者亚组中无症状性心脏缺血的频率， 验证当前的检测和监测系统，并澄清其他问题 重要的是一个全面的临床试验，如可用性 患者的随机化和对指定处方的依从性。 的 研究人群将由总共600名患有冠状动脉疾病的患者组成。 动脉疾病（CAD），通过血管造影和放射性核素研究记录， 他们通过运动压力测试和48小时 动态ECG监测：300例CAD和劳力性心绞痛患者， 300例无症状CAD患者。 在每个分层中，患者将 随机分为三种治疗策略：常规治疗、糖尿病指导治疗; 最大程度的医疗、动态心电图指导的阶梯式护理治疗;以及 机械性血管重建 主要终点将是减少 通过动态ECG检测到的完全和无症状心肌缺血 监测. 本合同适用于协调所有 数据收集、数据存储、研究相关分析，以及 组织指导委员会会议。

The purpose of this program is to conduct a multicenter trial as a pilot study to assess the feasibility of and test the methodology required for a full scale clinical trial of asymptomatic cardiac ischemia therapies. The primary objective is to determine the relative efficacy of usual care, stepped medical therapy, and mechanical revascularization to provide freedom from myocardial ischemia. Other objectives are to confirm the frequency of asymptomatic cardiac ischemia in the target patient subgroups, validate current detection and monitoring systems, and clarify other issues important for a full scale clinical trial, such as the availability of patients for randomization and compliance with assigned prescription. The study population will consist of a total of 600 patients with coronary artery disease (CAD), documented by angiographic and radionuclide studies, who have been identified by both exercise stress testing and 48 hour ambulatory ECG monitoring: 300 patients with CAD and exertional angina and 300 patients with asymptomatic CAD. Within each stratum, patients will be randomized to three treatment strategies: usual, symptom-guided care; maximal medical, ambulatory ECG-directed, stepped care therapy; and mechanical revascularization. The primary endpoint will be a reduction of total and asymptomatic cardiac ischemia detected by ambulatory ECG monitoring. This contract is for a Clinical Coordinating Center for coordinating all data collection, storage of data, analysis related to the study, and organizing the steering committee meetings.