Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
This study will be conducted at Cardiac Surgery Department, University Hospital Center Zagreb. It will be conducted in prospective observational fashion. Diabetic patients undergoing isolated, primary on-pump CABG will be consecutively recruited. Patients requiring urgent procedure will be excluded. Blood samples, both for conventional lab. findings (including HbA1c) and impedance aggregometry will be drawn prior to surgery and postoperatively on daily basis.
Cohort sample will be divided into two subgroups according to HbA1c level (Group 1 with HbA1c < 7% and Group 2 with HbA1c ≥ 7%, respectively). Respective subgroups will be compared for basic demographic data, laboratory findings including those obtained using platelet function testing, and for clinical outcomes, respectively.
Multiple-electrode aggregometry:
Whole blood aggregation will be determined using a new-generation impedance aggregometer (Multiplate analyzer; Roche Diagnostics). In brief, when platelets expose receptors on their surface they get activated and stick on the Multiplate sensor wires enhancing the electrical resistance between them. An increase in impedance is expressed in arbitrary area under the curve (AUC) units. Platelet aggregation is determined in response to stimulation with arachidonic acid (ASPI (aspirin-sensitive patients identification) test designed to evaluate the effect to acetylsalicylic acid (ASA)) and adenosine diphosphate (ADP) (ADP test designed to evaluate the effect of thienopyridines, such as clopidogrel).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with hemoglobin A1c < 7 | There will be no intervention administered to the group. The group will be observed for platelet function pre- and postoperatively. | ||
| Group with hemoglobin A1c ≥ 7% | There will be no intervention administered to the group. The group will be observed for platelet function pre- and postoperatively. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The level of preoperative HbA1c that will be a predictor of the higher prevalence of platelet resistance to the aspirin | 4 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Correlation between platelet ADP receptors reactivity (AUC) and the type of diabetes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Study population are the diabetic patients undergoing coronary artery bypass grafting at the department of cardiac surgery (The University Hospital Centre Zagreb, Croatia).
The patients will be sampled in consecutive fashion. Cohort sample will be divided into two subgroups according to HbA1c level (Group 1 with HbA1c < 7% and Group 2 with HbA1c ≥ 7%, respectively).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Zrno Mihaljević | Contact | 00385 1 2367 529 | martina_zrno@yahoo.com | |
| Mate Petričević | Contact | 00385 1 2367 529 | petricevic.mate@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Martina Zrno Mihaljević | Principal Investigator | |
| Bojan Biočina | Study Chair | |
| Mate Petričević |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Hospital Centre Zagreb, Department of cardiac surgery | Recruiting | Zagreb | 10 000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10320249 | Background | 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. doi: 10.1016/s0003-4975(99)00143-5. | |
| 15596675 | Background | 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. doi: 10.1378/chest.126.6.1789. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001791 | Blood Platelet Disorders |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 days after surgery |
| Correlation of diabetes duration and platelet reactivity (AUC) | 4 days after surgery |
| The prevalence of major adverse cardiovascular events (MAACE) in patients with HbA1c ≥ 7% | 3 months after surgery |
| Postoperative thoracic drainage in patients with the appropriate glucose regulation (Hba1c<7%) | within the first 5 days after surgery |
| Mortality | 3 months after surgery |
| The level of HbA1c, that will represent the reliable predictor of platelet hyperreactivity and MAACE | within the 3 months after surgery |
| Study Director |
| 15006999 | Background | 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. doi: 10.1161/01.CIR.0000121747.71054.79. Epub 2004 Mar 8. |
| 12771873 | Background | 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. doi: 10.1067/mtc.2003.181. |
| 18805264 | Background | 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. |
| 19674078 | Background | 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. |
| 24308225 | Background | 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. |
| 22203409 | Background | 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. |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |