Diabetes Mellitus Clinical Trial
Official title:
Relationship Between Level of Glycosylated Hemoglonin and Platelet Function in Patients Undergoing Coronary Artery Bypass Grafting
The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c) correlates to higher level of platelet reactivity assessed by impedance aggregometry in patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).
Status | Recruiting |
Enrollment | 130 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients undergoing isolated primary on-pump CABG - Elective surgery - Diabetic patients including IDDM and INDDM - Patients on antiplatelet therapy (aspirin and/or clopidogrel) pre- and postoperatively Exclusion Criteria: - Missing consent - Patients with cardiac surgical procedures other than isolated CABG - Patients on antiplatelet therapy other than aspirin or clopidogrel - Urgent surgery - Off-pump CABG - Rredo CABG |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Croatia | The University Hospital Centre Zagreb, Department of cardiac surgery | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Centre Zagreb |
Croatia,
Furnary AP, Gao G, Grunkemeier GL, Wu Y, Zerr KJ, Bookin SO, Floten HS, Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003 May;125(5):1007-21. — View Citation
Halkos ME, Puskas JD, Lattouf OM, Kilgo P, Kerendi F, Song HK, Guyton RA, Thourani VH. Elevated preoperative hemoglobin A1c level is predictive of adverse events after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2008 Sep;136(3):631-40. doi: 10.1016/j.jtcvs.2008.02.091. — View Citation
Kempfert J, Anger K, Rastan A, Krabbes S, Lehmann S, Garbade J, Sauer M, Walther T, Dhein S, Mohr FW. Postoperative development of aspirin resistance following coronary artery bypass. Eur J Clin Invest. 2009 Sep;39(9):769-74. doi: 10.1111/j.1365-2362.2009.02175.x. — View Citation
Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS. Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events. Circulation. 2004 Mar 30;109(12):1497-502. Epub 2004 Mar 8. — View Citation
Petricevic M, Biocina B, Konosic S, Burcar I, Siric F, Mihaljevic MZ, Ivancan V, Svetina L, Gasparovic H. Definition of acetylsalicylic acid resistance using whole blood impedance aggregometry in patients undergoing coronary artery surgery. Coll Antropol. 2013 Sep;37(3):833-9. — View Citation
Petricevic M, Biocina B, Konosic S, Kopjar T, Kunac N, Gasparovic H. Assessment of platelet function by whole blood impedance aggregometry in coronary artery bypass grafting patients on acetylsalicylic acid treatment may prompt a switch to dual antiplatelet therapy. Heart Vessels. 2013 Jan;28(1):57-65. doi: 10.1007/s00380-011-0216-3. Epub 2011 Dec 28. — View Citation
Thourani VH, Weintraub WS, Stein B, Gebhart SS, Craver JM, Jones EL, Guyton RA. Influence of diabetes mellitus on early and late outcome after coronary artery bypass grafting. Ann Thorac Surg. 1999 Apr;67(4):1045-52. — View Citation
Woods SE, Smith JM, Sohail S, Sarah A, Engle A. The influence of type 2 diabetes mellitus in patients undergoing coronary artery bypass graft surgery: an 8-year prospective cohort study. Chest. 2004 Dec;126(6):1789-95. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The level of preoperative HbA1c that will be a predictor of the higher prevalence of platelet resistance to the aspirin | 4 days after surgery | No | |
Secondary | Differences in perioperative aspirin resistance (AUC, area under the curve) between patients with insulin-dependent diabetes mellitus and patients with non-insulin-dependent diabetes mellitus | 4 days after surgery | No | |
Secondary | Correlation between platelet ADP receptors reactivity (AUC) and the type of diabetes | 4 days after surgery | No | |
Secondary | Correlation of diabetes duration and platelet reactivity (AUC) | 4 days after surgery | No | |
Secondary | The prevalence of major adverse cardiovascular events (MAACE) in patients with HbA1c = 7% | 3 months after surgery | No | |
Secondary | Postoperative thoracic drainage in patients with the appropriate glucose regulation (Hba1c<7%) | within the first 5 days after surgery | No | |
Secondary | Mortality | 3 months after surgery | No | |
Secondary | The level of HbA1c, that will represent the reliable predictor of platelet hyperreactivity and MAACE | within the 3 months after surgery | No |
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