CLINICAL UNIT FOR ASYMPTOMATIC CARDIAC ISCHEMIA PILOT

该计划的目的是作为试点进行多中心试验 评估可行性并测试所需方法学的研究 无症状性心肌缺血治疗的全面临床试验。这个 主要目标是确定常规护理的相对疗效， 阶梯式医疗和机械血管重建术提供 免于心肌缺血。其他目标是确认 目标患者亚组中无症状心肌缺血的频率， 验证当前的检测和监控系统，并澄清其他问题 对全面的临床试验很重要，例如可用 对患者进行随机分组，并遵守指定的处方。这个 研究人群将包括总共600名冠心病患者。 动脉疾病(CAD)，由血管造影术和放射性核素研究记录， 通过运动负荷测试和48小时 300例冠心病合并劳力性心绞痛患者的动态心电监测 300例无症状冠心病患者。在每个阶层中，患者将被 随机分为三种治疗策略：常规的、症状导向的治疗； 最大限度的医疗、动态心电指导、阶梯式护理疗法；以及 机械血管重建术。主端点将减少 动态心电图检测完全性和无症状性心肌缺血 监控。 这份合同是关于一个临床单元，用于患者入职、干预、 和数据收集。

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 Unit for patient accession, intervention, and data collection.