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

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HL061746-07S1
Application #
7546040
Study Section
Special Emphasis Panel (ZHL1-CSR-R (O2))
Program Officer
Goldberg, Suzanne H
Project Start
2000-09-15
Project End
2009-05-31
Budget Start
2008-01-01
Budget End
2009-05-31
Support Year
7
Fiscal Year
2008
Total Cost
$230,211
Indirect Cost
Name
Saint Louis University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
050220722
City
Saint Louis
State
MO
Country
United States
Zip Code
63103
Everett, Brendan M; Brooks, Maria Mori; Vlachos, Helen E A et al. (2016) Sex Differences in Cardiac Troponin and the Risk of Death or Major Cardiovascular Events. J Am Coll Cardiol 68:978-80
Bertolet, Marnie; Brooks, Maria M; Bittner, Vera (2016) Tree-based identification of subgroups for time-varying covariate survival data. Stat Methods Med Res 25:488-501
Wolk, Robert; Bertolet, Marnie; Singh, Prachi et al. (2016) Prognostic Value of Adipokines in Predicting Cardiovascular Outcome: Explaining the Obesity Paradox. Mayo Clin Proc 91:858-66
Singh, Ashima; Schaff, Hartzell V; Mori Brooks, Maria et al. (2016) On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. Eur J Cardiothorac Surg 49:406-16
Wolk, Robert; Bertolet, Marnie; Brooks, Maria M et al. (2016) Differential effects of insulin sensitization and insulin provision treatment strategies on concentrations of circulating adipokines in patients with diabetes and coronary artery disease in the BARI 2D trial. Eur J Prev Cardiol 23:50-8
Everett, Brendan M; Brooks, Maria Mori; Vlachos, Helen E A et al. (2015) Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes. N Engl J Med 373:610-20
Magee, Michelle F; Tamis-Holland, Jacqueline E; Lu, Jiang et al. (2015) Sex, Prescribing Practices and Guideline Recommended, Blood Pressure, and LDL Cholesterol Targets at Baseline in the BARI 2D Trial. Int J Endocrinol 2015:610239
Zonszein, Joel; Lombardero, Manuel; Ismail-Beigi, Faramarz et al. (2015) Triglyceride High-Density Lipoprotein Ratios Predict Glycemia-Lowering in Response to Insulin Sensitizing Drugs in Type 2 Diabetes: A Post Hoc Analysis of the BARI 2D. J Diabetes Res 2015:129891
Bittner, Vera; Bertolet, Marnie; Barraza Felix, Rafael et al. (2015) Comprehensive Cardiovascular Risk Factor Control Improves Survival: The BARI 2D Trial. J Am Coll Cardiol 66:765-773
Sako, Edward Y; Brooks, Maria Mori; Hardison, Regina M et al. (2014) Coronary artery bypass in patients with type 2 diabetes: experience from the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. J Thorac Cardiovasc Surg 148:1268-72

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