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Diabetes MellitusNCT02711124

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

An observational study of Diabetes Mellitus and Complication of Coronary Artery Bypass Graft, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Any age
How many people
130 participants
Where
1 siteCroatia
Study dates
Feb 2014to Aug 2016
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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).

Who may be able to join

  • Patients undergoing isolated primary on-pump CABG
  • 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

Who cannot join

  • 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
  • Redo CABG

Trial locations and contacts

1 site in 1 country.

Martina Zrno Mihaljević contact

00385 1 2367 529

martina_zrno@yahoo.com

Mate Petričević contact

00385 1 2367 529

petricevic.mate@gmail.com

Croatia1 site, 1 recruiting

  • The University Hospital Centre Zagreb, Department of cardiac surgery

    Zagreb, 10 000

    Martina Zrno Mihaljević, 00385 1 2367 529, martina_zrno@yahoo.com

    Mate Petričević, 00385 1 2367 529, petricevic.mate@gmail.com

    Recruiting

Other trials in Croatia

About this study

Official title: Relationship Between Level of Glycosylated Hemoglobin 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).

Read the detailed 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; 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).

Keywords
hemoglobin A1c, coronary artery bypass grafting, impedance aggregometry, platelet reactivity, clinical outcomes
Medical subject headings
Diabetes Mellitus, Blood Platelet Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02711124
Study groupRoleWhat they receive
Group with hemoglobin A1c < 7There 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The level of preoperative HbA1c that will be a predictor of the higher prevalence of platelet resistance to the aspirin

    Measured: 4 days after surgery

Secondary outcomes (7)

  1. 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

    Measured: 4 days after surgery

  2. Correlation between platelet ADP receptors reactivity (AUC) and the type of diabetes

    Measured: 4 days after surgery

  3. Correlation of diabetes duration and platelet reactivity (AUC)

    Measured: 4 days after surgery

  4. The prevalence of major adverse cardiovascular events (MAACE) in patients with HbA1c ≥ 7%

    Measured: 3 months after surgery

  5. Postoperative thoracic drainage in patients with the appropriate glucose regulation (Hba1c<7%)

    Measured: within the first 5 days after surgery

  6. Mortality

    Measured: 3 months after surgery

  7. The level of HbA1c, that will represent the reliable predictor of platelet hyperreactivity and MAACE

    Measured: within the 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study startFeb 2014
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02711124
Sponsor's protocol ID
KBC Zagreb
Status last verified
Mar 2016
First submitted
7 Mar 2016
Last updated
22 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 10320249

  • 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.

    PubMed 15596675

  • 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.

    PubMed 15006999

  • 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.

    PubMed 12771873

  • 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.

    PubMed 18805264

  • 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.

    PubMed 19674078

  • 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.

    PubMed 24308225

  • 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.

    PubMed 22203409

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Complication of Coronary Artery Bypass Graft, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martina Zrno Mihaljević (00385 1 2367 529, martina_zrno@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of preoperative HbA1c that will be a predictor of the higher prevalence of platelet resistance to the aspirin (time frame: 4 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02711124, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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