BARI II GRANT PROPOSAL FOR ECG CORE LABORATORY

对冠心病稳定的2型糖尿病患者进行的BAR！II试验 血运重建将测试1)最初的血运重建策略(PTCA或CABG)是否具有侵略性 与积极的医疗管理相比，糖尿病的医疗管理导致更低的5年死亡率 以延迟或无血管重建的初始策略进行管理，以及2)最佳的方法 在设定统一的HbAjC目标的情况下的高血糖管理。长期目标和具体目标 这项建议的目的是对所有与BARIII患者相关的心电文件进行分类，以确定基线 心电图对长期结果的预测，并对与以下因素相关的所有心肌梗死/缺血事件进行分类 治疗策略经过5年以上的随访检验。心肌缺血事件将按以下方式分类 连续的心电图改变、心肌酶异常和临床症状。心肌梗死已确诊 如Q波(在常规随访中发现有症状或无症状)、非Q波心肌梗死或不稳定心绞痛 与导致入院的新的心电图变化相关或不相关；连续的心电图变化将 使用Novacode检测，这是一种用于大规模临床试验的心电比较程序。心脏 将使用世卫组织标准对酶异常进行分类。这项提案的结果将使 主要研究次要终点BARI II中心肌缺血事件发生率的测定。房租 将比较导致入院的心肌梗死和心肌缺血事件的 患者随机接受初始药物治疗或初始冠状动脉血管重建术，并接受胰岛素治疗 糖尿病治疗方案与胰岛素增敏性糖尿病治疗方案。对预后的影响 将确定心源性死亡率和总死亡率的基线和后续新的后续心电变化 死亡率。 不同地点(S)(组织、市、州) 圣路易斯大学核心心肌梗死/缺血/心电实验室 南布伦特伍德大道1034号 1550号套房 密苏里州圣路易斯，邮编：63117 关键人员。请参阅第11页上的说明。根据需要使用续页以如下所示的格式提供所需信息。 名称组织？项目中的角色 伯纳德·R·查特曼，圣路易斯大学医学博士。医学院。聚酰亚胺 圣路易斯大学医学博士杰罗姆·D·科恩医学院。研究调查员 伊戈尔·古萨克，医学博士，圣路易斯大学博士医学院。研究调查员 卡伦·斯托克，圣路易斯大学MBA。医学院。实验室督导员 小灵通398(4/98版)第2页BB 在整个应用程序的底部连续编号页码。不要使用3a、3b等后缀。 CC二级主管/程序主管(最后、第一、中间)：？b Chaitman“Bernard R 在每一张打印页和每一续页的顶部输入主要调查员/项目主管的姓名。(有关类型规格，请参阅 第6页上的说明。) 研究补助金 目录 页码 正面第1页 描述，

The BAR!II trial of type 2 diabetic patients with stable CAD.who are candidates for coronary revascularization will test 1) if an initial strategy of revascularization (PTCA or CABG) and aggressive medical management of diabetes results in lower 5 year mortality compared to aggressive medical management with an initial strategy of delayed or no revascularization, and 2) the optimal approach of hyperglycemia management in the setting of.auniform HbAjC goal. The long-term objective and specific aims of this proposal are to classify all ECG documents associated with BARIII patients to identify baseline ECG predictors of long-term outcome, and to classify all myocardial infarct/ischemic events associatedwith the treatment strategies tested over 5 years of follow-up. Myocardial ischemic events will be classifed by serial ECG changes, cardiac enzyme abnormalities, and clinical symptoms. Myocardial infarction is defmedj as Q wave (symptomatic or silent detected during routine follow-up), non Q wave MI, or unstable angina associated with or without new ECG changes resulting in hospital admission; Serial ECG change will be detected using the Novacode, an ECG comparison program used in large scale clinical trials. Cardiac enzyme abnormalities will be classified using WHO criteria. The results of this proposal will allow determination of myocardial ischemic event rates in BARI II, a major study secondary endpoint. The rates of myocardial infarction and myocardial ischemic events leading to hospital admission will be compared in patients randomized to initial medical therapy or initial coronary revascularization, and to insulin providing diabetes treatment protocol vs. insulin sensitizing diabetes treatment protocol. The prognostic impact of baseline and subsequent new follow-up ECG changes will be determined for cardiac mortality and total mortality. DERFORMANCE SITE(S) (organization, city, state) St. Louis University Core Myocardial Infarct/Ischemia/ECG laboratory 1034 South Brentwood Blvd. Suite 1550 St. Louis, MO 63117 KEY PERSONNEL. See instructions on Page 11. Use continuation pages as neededto provide the required information in the format shown below. Name Organization ¿ Role on Project Bernard R. Chaitman, M.D. St. Louis Univ. School of Med. PI Jerome D. Cohen, M.D. St. Louis Univ. School of Med. Study investigator Igor Gussak, M.D.,PhD St. Louis Univ. School of Med. Study Investigator Karen Stocke, MBA St. Louis Univ. School of Med. Laboratory Supervisor PHS 398 (Rev. 4/98) Page 2 BB Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. CC Principal Ii<ftgator/Proqram Director (Last, first, middle): ¿b Chaitman" Bernard R Type the name of the principal'investigator/program director at the top of each printed page and each continuation page. (For type specifications, see instructions on page 6.) RESEARCH GRANT TABLE OF CONTENTS Page Numbers Face Page 1 Description,