BARI II GRANT PROPOSAL FOR ECG CORE LABORATORY

酒吧！II型糖尿病患者的试验稳定的CAD。谁是冠状动脉候选人 血运重建将测试1）血运重建的初始策略（PTCA或CABG）和积极的 与积极的药物治疗相比，糖尿病的药物治疗可降低5年死亡率 采用延迟或不进行血运重建的初始策略进行管理，以及2） 在设定统一HbAjC目标的情况下进行高血糖管理。长期目标和具体 本提案的目的是对所有与BARIII患者相关的ECG文件进行分类，以确定基线 长期预后的ECG预测因子，并对所有与 在5年的随访中测试了治疗策略。心肌缺血事件将按以下分类： 一系列心电图改变、心肌酶异常和临床症状。心肌梗死定义j 作为Q波（常规随访期间检测到的症状性或无症状性）、非Q波MI或不稳定型心绞痛 与或不与导致住院的新ECG变化相关;将连续ECG变化 使用Novacode检测，这是一种用于大规模临床试验的ECG比较程序。心脏 将使用WHO标准对酶异常进行分类。这项提案的结果将允许 确定巴里II中的心肌缺血事件发生率，这是一项主要研究次要终点。率 将比较导致住院的心肌梗死和心肌缺血事件的发生率， 患者随机接受初始药物治疗或初始冠状动脉血运重建，并接受胰岛素治疗 糖尿病治疗方案与胰岛素增敏糖尿病治疗方案。的预后影响 将确定心源性死亡率和总死亡率的基线和后续新随访ECG变化 mortality. 执行地点（组织、城市、州） 圣路易斯大学核心心肌缺血/心电图实验室 布伦特伍德大道南1034号 1550套房 圣Louis，MO 63117 关键人员。参见第11页的说明。根据需要使用续页，以下列格式提供所需信息。 名称组织<$项目角色 伯纳德河Chaitman，医学博士圣路易斯大学医学院 杰罗姆D.科恩医学博士圣路易斯大学医学院研究员 Igor Gussak，医学博士，圣路易斯大学医学院博士研究者 Karen Stocke，圣路易斯大学医学院工商管理硕士，实验室主管 PHS 398（Rev. 4/98）第2 BB页 在整个应用程序的底部连续编号页面。不要使用后缀，如3a，3b。 CC主要II<ftgator/Proqram Director（Last，first，middle）：B Chaitman”Bernard R 在打印页和续页的顶部键入主要研究者/项目负责人的姓名。(For型号规格，见 第6页的说明）。 研究资助 目录 页码 首页1 说明，

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,