CLINICAL UNIT FOR ASYMPTOMATIC CARDIAC ISCHEMIA PILOT

无症状心脏缺血飞行员的临床单位

• 批准号: 2317803
• 负责人: ANDREW Peter SELWYN
• 金额: $ 13.82万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-12-10 至 1993-12-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2317803
• 关键词: CLINICAL; UNIT; ASYMPTOMATIC; CARDIAC; ISCHEMIA

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 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.

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，并作为患者的可用性， 随机化和对指定处方的依从性。 研究 人群将由总共600名冠状动脉患者组成 疾病（CAD），通过血管造影和放射性核素研究记录， 通过运动负荷试验和48小时门诊 心电图监测：300例CAD和劳累性心绞痛患者，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. 该合同是为临床单位的病人登记，干预， 和数据收集。