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NCT Number: NCT07451873

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.

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Key information

Conditions

Coronary Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osijek University Hospital

Osijek, 31000, Croatia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Other outcomes

  1. Blood pressure

    Time frame: Perioperative/Periprocedural

    Automatic oscillometric measurement of systolic and diastolic blood measurement (mmHg)

  2. Heart rate

    Time frame: Perioperative/Periprocedural

    Automatic oscillometric measurement of heart rate (bpm)

  3. Body Mass Index

    Time frame: Perioperative/Periprocedural

    Measurement of BMI (kg/m2)

  4. 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).

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Drenjančević, MD, PhD

CONTACT

[email protected]

+385912241406

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Registry information

Official study title

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

Acronym: GlikoOxEND

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 5, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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