BARI II GRANT PROPOSAL FOR ECG CORE LABORATORY

酒吧!2型糖尿病合并稳定型冠心病的临床研究。谁是冠状动脉的候选者

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,