CORE ELECTROCARDIOGRAPHIC LABORATORY--BARI TRIAL

核心心电实验室(CEL)的主要目标是 旁路血管成形术血运重建调查(BARI)试验为：(1) 监督休息和运动心电数据的质量；(2)对静息心电进行分类 根据明尼苏达编码对运动心电数据进行分析；(3)分类 疑似心肌梗死事件，BARI的主要终点。全 协议REST ECG(年度、程序和疑似MI事件)、数据表单 对于可疑的心肌梗死事件，和礼仪锻炼 心电图将被送往CEL进行分析。CEL是 强制将少报或多报事件的可能性降至最低 各临床单位心肌梗死发生率及下降 主要中心间变异在检测心肌梗死中的可能性 心肌梗死。大型核心心电实验室的需求 多中心临床试验已经确立。圣路易斯大学 CEL自1988年12月以来一直得到资助，以支持巴里临床 努力并开发了用于运动心电分析的定制软件， 自动确定明尼苏达州代码的软件 允许对REST进行连续比较的测量矩阵和软件 心电图仪。分析后的心电数据以电子方式传输 到数据协调中心。在这项竞争性拨款续期中， 将允许所有患者完成五年的随访并延长 入学后10年跟踪，圣路易斯大学CEL 请求继续提供资金，以允许以上所有项目以及分类 临床表现可疑心肌梗死事件，心脏 酶数据和心电分析对治疗分配是盲目的。A 2步 明尼苏达州恶化Q波编码仅用于确定程序 相关的心肌梗死，而对于非手术相关的心肌梗死， 心肌梗死的诊断基于明尼苏达Q波两步恶化 代码，胸痛超过20分钟的病史，以及连续的心脏 总CK超过正常两倍且CK-MB阳性的酶数据 其中，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的经验 记录和分类心肌梗死/缺血事件，并作为 美国国立卫生研究院赞助的心电和心肌梗死分类核心设施 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.