NCT02711124

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

March 7, 2016

Last Update Submit

March 19, 2016

Conditions

Diabetes MellitusComplication of Coronary Artery Bypass GraftBlood Platelet Disorders

Keywords

hemoglobin A1ccoronary artery bypass graftingimpedance aggregometryplatelet reactivityclinical outcomes

Outcome Measures

Primary Outcomes (1)

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

    4 days after surgery

Secondary Outcomes (7)

  • 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

    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

  • +2 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University Hospital Centre Zagreb, Department of cardiac surgery

Zagreb, 10 000, Croatia

RECRUITING

Related Publications (8)

  • 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.

    PMID: 10320249BACKGROUND

  • 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.

    PMID: 15596675BACKGROUND

  • 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.

    PMID: 15006999BACKGROUND

  • 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.

    PMID: 12771873BACKGROUND

  • 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.

    PMID: 18805264BACKGROUND

  • 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.

    PMID: 19674078BACKGROUND

  • 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.

    PMID: 24308225BACKGROUND

  • 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.

    PMID: 22203409BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusBlood Platelet Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Martina Zrno Mihaljević

    PRINCIPAL INVESTIGATOR

  • Bojan Biočina

    STUDY CHAIR

  • Mate Petričević

    STUDY DIRECTOR

Central Study Contacts

Martina Zrno Mihaljević

CONTACT

00385 1 2367 529martina_zrno@yahoo.com

Mate Petričević

CONTACT

00385 1 2367 529petricevic.mate@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Surgeon at the Department of cardiac surgery

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 17, 2016

Study Start

February 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 22, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)