Coronary Heart DiseaseGlikoOxENDNCT07451873
Glycocalyx and Oxidative Stress in Endothelial Function (Part 2)
An observational study of Coronary Heart Disease, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 35 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective coronary artery bypass grafting (CABG)
Who may be able to join
- adult patients of both sexes over 18 years of age
- Caucasian
- undergoing elective coronary artery bypass grafting (CABG)
- provided written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital
Osijek, 31000
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Keywords
- Glycocalyx, Inflammation, Oxidative stress, Endothelium, Coronary Artery Disease, Myocardial Revascularization
- Medical subject headings
- Coronary Disease, Inflammation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Endothelial glycocalyx
Measurement of the thickness of endothelial glycocalyx in coronary heart disease patients before and after bypass surgery - measured by Glycocheck
Measured: Perioperative/Periprocedural
Secondary outcomes (6)
Bypass graft sample reactivity
Determine the reactivity of the bypass graft sample in in vitro experiments - measured by isolated vessel setup
Measured: Baseline, at one time point
Endothelial glycocalyx soluble markers
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)
Measured: Perioperative/Periprocedural
Intracellular oxidative stress production
Quantification of intracellular oxidative stress production from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by flow cytometry (DCF-DA and DHE)
Measured: Perioperative/Periprocedural
Inflammation
Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - measured by Luminex assay (cytokine profile) and flow cytometry (macrophage frequency)
Measured: Perioperative/Periprocedural
Antioxidant capacity
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)
Measured: Perioperative/Periprocedural
Oxidative stress biomarkers
Quantification of oxidative stress biomarkers from serum samples in the specified groups - measured by ELISA assays (MPO, 8-iso prostaglandin F2a, OxLDL, AOPP)
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451873
- Sponsor's protocol ID
- R1-10842/2025
- Acronym
- GlikoOxEND
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 2)
- ClinicalTrials.gov ID
- NCT07451873
- Acronym / sponsor ID
- GlikoOxEND / R1-10842/2025
- Conditions
- Coronary Heart Disease
- Keywords
- Glycocalyx, Inflammation, Oxidative stress, Endothelium, Coronary Artery Disease, Myocardial Revascularization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective coronary artery bypass grafting (CABG)
Key inclusion criteria (4 listed)
- adult patients of both sexes over 18 years of age
- Caucasian
- undergoing elective coronary artery bypass grafting (CABG)
- provided written informed consent
Key exclusion criteria (6 listed)
- emergency surgery
- sepsis or severe systemic inflammation before surgery
- severe renal or hepatic insufficiency
- immunosuppression
- serious comorbidities (e.g., active cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Bypass graft sample reactivity
Time frame: Baseline, at one time point
Endothelial glycocalyx soluble markers
Time frame: Perioperative/Periprocedural
Intracellular oxidative stress production
Time frame: Perioperative/Periprocedural
Inflammation
Time frame: Perioperative/Periprocedural
Antioxidant capacity
Time frame: Perioperative/Periprocedural
Oxidative stress biomarkers
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Josip Juraj Strossmayer University of Osijek 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Drenjančević, MD, PhD (+385912241406, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial glycocalyx (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.