Relationship Between Level of Hemoglobin A1c and Platelet Function in Patients Undergoing Cardiac Surgery
NCT ID: NCT02711124
Last Updated: 2016-03-22
Study Results
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Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2014-02-28
2016-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Elective surgery
* Diabetic patients including insulin-dependent diabetes mellitus (IDDM) and non-insulin-dependent diabetes mellitus NIDDM
* Patients on antiplatelet therapy (aspirin and/or clopidogrel) pre- and postoperatively
Exclusion Criteria
* Patients with cardiac surgical procedures other than isolated CABG
* Patients on antiplatelet therapy other than aspirin or clopidogrel
* Urgent surgery
* Off-pump CABG
* Redo CABG
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
Responsible Party
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Martina Zrno Mihaljević, MD
Principal Investigator, Surgeon at the Department of cardiac surgery
Principal Investigators
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Martina Zrno Mihaljević
Role: PRINCIPAL_INVESTIGATOR
Bojan Biočina
Role: STUDY_CHAIR
Mate Petričević
Role: STUDY_DIRECTOR
Locations
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The University Hospital Centre Zagreb, Department of cardiac surgery
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KBC Zagreb
Identifier Type: -
Identifier Source: org_study_id
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