Glycocalyx and Oxidative Stress in Endothelial Function (Part 2) (GlikoOxEND)

March 5, 2026 updated by: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek

The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 2)

The primary research objective of the project is to determine the role of eGC in microvascular reactivity in patients with coronary heart disease (CHD) before and after bypass grafting (cross-sectional study 2).The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields, improving conditions and resources for scientific work, and increasing international cooperation, in line with strategic objective 1: raising scientific excellence. The results of the project could provide pathophysiological insight into the development and maintenance of endothelial dysfunction in CVD, as well as identify new biomarkers for CVD.

Study Overview

Status

Recruiting

Detailed Description

The primary objective of this project is to determine the association between endothelial glycocalyx (eGC) and myocardial revascularization in patients undergoing coronary artery bypass grafting and clinical outcomes of treatment (observational prospective study 2).

Specific objective 2.1: Measure eGC thickness in coronary artery disease patients before and after surgery.

Specific objective 2.2: Determine the reactivity of the bypass graft sample in in vitro experiments.

Specific objective 2.3: Quantify soluble markers of eGC, oxidative stress, and inflammation from serum and PBMC samples, as well as antioxidant capacity.

Specific objective 2.4: Determine the association between the results of functional tests, eGC, and markers from specific objective 2.3 with clinical outcomes of treatment.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Osijek, Croatia, 31000
        • Recruiting
        • Osijek University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients undergoing elective coronary artery bypass grafting (CABG)

Description

Inclusion Criteria:

  • adult patients of both sexes over 18 years of age
  • Caucasian
  • undergoing elective coronary artery bypass grafting (CABG)
  • provided written informed consent

Exclusion Criteria:

  • emergency surgery
  • sepsis or severe systemic inflammation before surgery
  • severe renal or hepatic insufficiency
  • immunosuppression
  • serious comorbidities (e.g., active cancer)
  • therapies that could affect oxidative stress (e.g., high doses of corticosteroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Coronary Heart Disease (CHD) patients
Adult patients of both sexes over 18 years of age, undergoing elective coronary artery bypass grafting (CABG) and who provided written informed consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial glycocalyx
Time Frame: Perioperative/Periprocedural
Measurement of the thickness of endothelial glycocalyx in coronary heart disease patients before and after bypass surgery - measured by Glycocheck
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bypass graft sample reactivity
Time Frame: Baseline, at one time point
Determine the reactivity of the bypass graft sample in in vitro experiments - measured by isolated vessel setup
Baseline, at one time point
Endothelial glycocalyx soluble markers
Time Frame: Perioperative/Periprocedural
Quantification of soluble markers of endothelial glycocalyx from serum or plasma samples in the specified groups - measured by ELISA assays (syndecan-1, syndecan-4, glypican-1, MMP-9)
Perioperative/Periprocedural
Inflammation
Time Frame: Perioperative/Periprocedural
Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by Luminex assay (cytokine profile) and flow cytometry (macrophage frequency)
Perioperative/Periprocedural
Antioxidant capacity
Time Frame: Perioperative/Periprocedural
Quantification of antioxidative enzyme concentration and activation from serum samples in the specified groups - measured by ELISA assays and UV-Vis spectrophotometry (SOD, GPx, CAT)
Perioperative/Periprocedural
Intracellular oxidative stress production
Time Frame: Perioperative/Periprocedural
Quantification of intracellular oxidative stress production from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by flow cytometry (DCF-DA and DHE)
Perioperative/Periprocedural
Oxidative stress biomarkers
Time Frame: Perioperative/Periprocedural
Quantification of oxidative stress biomarkers from serum samples in the specified groups - measured by ELISA assays (MPO, 8-iso prostaglandin F2a, OxLDL, AOPP)
Perioperative/Periprocedural

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Perioperative/Periprocedural
Automatic oscillometric measurement of systolic and diastolic blood measurement (mmHg)
Perioperative/Periprocedural
Heart rate
Time Frame: Perioperative/Periprocedural
Automatic oscillometric measurement of heart rate (bpm)
Perioperative/Periprocedural
Body Mass Index
Time Frame: Perioperative/Periprocedural
Measurement of BMI (kg/m2)
Perioperative/Periprocedural
Body composition
Time Frame: Perioperative/Periprocedural
Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg).
Perioperative/Periprocedural
Body fluid status
Time Frame: Perioperative/Periprocedural
Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L).
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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