CORE ELECTROCARDIOGRAPHIC LABORATORY--BARI TRIAL

核心心电图实验室（CEL）的主要目的是 旁路血管成形术血运重建研究（巴里）试验是：（1）至 监督静息和运动ECG数据的质量;（2）对静息ECG进行分类 根据Minnesota编码，对运动心电图数据进行分类 疑似心肌梗死事件，巴里的主要终点。 所有 方案静息ECG（年度、手术和疑似MI事件），数据表 疑似心肌梗死事件和方案运动 将心电图发送至CEL进行分析。 CEL是 强制性，以最大限度地减少少报或多报事件的可能性 从个别临床单位和降低心肌梗死率 在检测中存在主要中心间变异性的可能性 心肌梗死 需要大型核心心电图实验室 多中心临床试验已经建立。 圣路易斯大学 自1988年12月以来，CEL一直获得资助，以支持巴里临床 努力并开发了运动心电图分析的定制软件， 软件自动确定明尼苏达州代码的基础上， 测量矩阵和软件，允许对剩余的 心电图 分析的ECG数据以电子方式传输 数据协调中心。 在这次竞争性的赠款更新中， 将允许所有患者完成5年随访，并延长 入学后10年的随访，圣路易斯大学CEL是 要求继续提供资金，以允许所有上述以及分类 基于临床表现的疑似心肌梗死事件，心脏 酶数据和ECG分析，对治疗分配设盲。 A 2步 明尼苏达Q波代码中的恶化仅用于确定程序 相关的心肌梗死，而对于非手术相关的梗死， 基于明尼苏达Q波的2步恶化诊断梗死 代码，胸痛病史超过20分钟， 总CK超过正常值两倍且CK-MB呈阳性的酶数据 MB优先于总CK。 圣路易斯大学CEL 多年使用明尼苏达编码和分析运动心电图的经验 记录和分类心肌梗死/缺血事件，并作为 一个ECG和MI分类核心设施，用于几个NIH赞助的 临床试验

The primary aim of the Core Electrocardiographic Laboratory (CEL) in the Bypass Angioplasty Revascularization Investigation (BARI) trial is: (1) to oversee the quality of rest and exercise ECG data; (2) classify rest ECGs according to Minnesota code and analyze exercise ECG data; (3) classify suspected myocardial infarct events, a major end point in BARI. All protocol rest ECGs (annual, procedure, and suspected MI events), data forms for suspected myocardial infarct events, and protocol exercise electrocardiograms will be sent to the CEL for analysis. The CEL is mandatory to minimize the possibility of under or over reporting incident rates of myocardial infarction from individual clinical units and reduce the potential for major intercenter variability in the detection of myocardial infarction. The need for core ECG laboratories in large multicenter clinical trials is well established. The St. Louis University CEL has been funded since December of 1988 to support the BARI clinical effort and has development customized software for exercise ECG analysis, software which automatically determine Minnesota code based on a measurement matrix and software which permits serial comparison of rest electrocardiograms. The analyzed ECG data are electronically transmitted to the DATA Coordinating Center. In this competitive grant renewal which will permit completion of five year follow-up for all patients and extended follow up for 10 years after enrollment, the St. Louis University CEL is requesting continued funding to permit all of the above as well as classify suspected myocardial infarct events based on clinical presentation, cardiac enzyme data, and ECG analysis, blinded to treatment assignment. A 2 step worsening in Minnesota Q wave code only is used to determine procedure related myocardial infarcts whereas for nonprocedure related infarcts, the diagnosis of infarction is based on 2 step worsening in Minnesota Q wave code, a history of chest pain greater than 20 minutes, and serial cardiac enzyme data in which total CK exceeds twice normal and CK-MB is positive with MB taking precedence over total CK. The St. Louis University CEL has years of experience using the Minnesota code and in analyzing exercise ECG documents and classifying myocardial infarct/ischemic events, and serves as an ECG and MI classification core facility for several NIH sponsored clinical trials.