- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451873
Glycocalyx and Oxidative Stress in Endothelial Function (Part 2) (GlikoOxEND)
The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 2)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ines Drenjančević, MD, PhD
- Phone Number: +385912241406
- Email: ines.drenjancevic@mefos.hr
Study Locations
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Osijek, Croatia, 31000
- Recruiting
- Osijek University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Endothelial glycocalyx
Time Frame: Perioperative/Periprocedural
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Measurement of the thickness of endothelial glycocalyx in coronary heart disease patients before and after bypass surgery - measured by Glycocheck
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Perioperative/Periprocedural
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bypass graft sample reactivity
Time Frame: Baseline, at one time point
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Determine the reactivity of the bypass graft sample in in vitro experiments - measured by isolated vessel setup
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Baseline, at one time point
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Endothelial glycocalyx soluble markers
Time Frame: Perioperative/Periprocedural
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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)
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Perioperative/Periprocedural
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Inflammation
Time Frame: Perioperative/Periprocedural
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Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by Luminex assay (cytokine profile) and flow cytometry (macrophage frequency)
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Perioperative/Periprocedural
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Antioxidant capacity
Time Frame: Perioperative/Periprocedural
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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)
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Perioperative/Periprocedural
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Intracellular oxidative stress production
Time Frame: Perioperative/Periprocedural
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Quantification of intracellular oxidative stress production from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by flow cytometry (DCF-DA and DHE)
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Perioperative/Periprocedural
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Oxidative stress biomarkers
Time Frame: Perioperative/Periprocedural
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Quantification of oxidative stress biomarkers from serum samples in the specified groups - measured by ELISA assays (MPO, 8-iso prostaglandin F2a, OxLDL, AOPP)
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Perioperative/Periprocedural
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: Perioperative/Periprocedural
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Automatic oscillometric measurement of systolic and diastolic blood measurement (mmHg)
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Perioperative/Periprocedural
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Heart rate
Time Frame: Perioperative/Periprocedural
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Automatic oscillometric measurement of heart rate (bpm)
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Perioperative/Periprocedural
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Body Mass Index
Time Frame: Perioperative/Periprocedural
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Measurement of BMI (kg/m2)
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Perioperative/Periprocedural
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Body composition
Time Frame: Perioperative/Periprocedural
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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).
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Perioperative/Periprocedural
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Body fluid status
Time Frame: Perioperative/Periprocedural
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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).
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Perioperative/Periprocedural
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R1-10842/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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