Relationship Between Level of Hemoglonin A1c and Platelet Function in Patients Undergoing Cardiac Surgery

Diabetes Mellitus Clinical Trial

Official title:

Relationship Between Level of Glycosylated Hemoglonin and Platelet Function in Patients Undergoing Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02711124
• Other study ID #: KBC Zagreb
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 11, 2016
• Start date: February 2014
• Est. completion date: August 2016

Study information

• Verified date: March 2016
• Source: Clinical Hospital Centre Zagreb
• Contact: Martina Zrno Mihaljevic
• Phone: 00385 1 2367 529
• Email: martina_zrno[@]yahoo.com
• Is FDA regulated: No
• Health authority: Croatia: Ethics CommitteeCroatia: Ministry of Health and Social Care
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Description:

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).

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Complication of Coronary Artery Bypass Graft
• Diabetes Mellitus

Locations

Country	Name	City	State
Croatia	The University Hospital Centre Zagreb, Department of cardiac surgery	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (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. — 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

Outcome

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