CLINICAL COORDINATING CENTER FOR ACIP

ACIP 临床协调中心

• 批准号: 2317712
• 负责人: GENELL L KNATTERUD
• 金额: $ 61.75万
• 依托单位: MARYLAND MEDICAL RESEARCH INSTITUTE, INC
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-11-15 至 1994-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2317712
• 关键词: CLINICAL; COORDINATING; CENTER; ACIP

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.

该计划的目的是作为飞行员进行多中心试验 研究评估和测试A的可行性和测试的研究 无症状心脏缺血疗法的全尺度临床试验。 这 主要目的是确定常规护理的相对功效， 阶梯疗法和机械血运重建 摆脱心肌缺血的自由。 其他目标是确认 目标患者亚组中无症状心脏缺血的频率， 验证当前的检测和监视系统，并澄清其他问题 对于全尺度临床试验很重要，例如可用性 随机分配和遵守指定处方的患者。 这 研究人群将由600例冠状动脉组成 血管造影和放射性核素研究记录的动脉疾病（CAD）， 通过运动压力测试和48小时都可以识别 卧床心电图监测：300例CAD和劳累心绞痛患者 300例无症状CAD患者。 在每个层中，患者将是 随机分为三种治疗策略：通常，症状引导的护理； 最大医学，非门诊ECG指导的阶梯护理疗法；和 机械血运重建。 主要终点将减少 通过卧床心电图检测到的总和无症状的心脏缺血 监视。 该合同是用于协调所有的临床协调中心 数据收集，数据存储，与研究相关的分析以及 组织指导委员会会议。