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).
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; Dynabyte Medical, Munich, Germany). 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).
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Observational Model: Cohort, Time Perspective: Prospective
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