StrokeDEGIMTNCT07292974
ENDOTHELIAL GLYCOCALYX AND INFLAMMATORY RESPONSE CHANGES IN PATIENTS WITH ACUTE STROKE UNDERGOING MECHANICAL THROMBECTOMY
An observational study of Stroke and Thrombectomy, run by Clinical Hospital Centre Zagreb.
Trial summary
Ischemic stroke (IS) is one of the leading causes of mortality and disability. Treatment of IS is based on reperfusion methods, thrombolysis and mechanical thrombectomy (MT). However, there are significant limitations in their implementation and success. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Thrombectomy, Endothelial Glycocalyx
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 2030
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients older than 18 years with a diagnosis of acute IS confirmed by brain CT or MRI, and to whom MT will be performed.
Inclusion Criteria: all patients older than 18 years with a diagnosis of acute IS confirmed by brain CT or MRI, and to whom MT will be performed, regardless of whether they are previously received thrombolysis.
Exclusion Criteria: patients under the age of 18, patients with diagnosed with hemorrhagic stroke, patients with acute infection, autoimmune illness, malignant disease, trauma, pregnant women or patients who will refuse to participate in research.
About this study
Official title: DYNAMIC CHANGES OF ENDOTHELIAL GLYCOCALYX AND INFLAMMATORY RESPONSE IN PATIENTS WITH ACUTE STROKE TREATED WITH MECHANICAL THROMBECTOMY
Ischemic stroke (IS) is one of the leading causes of mortality and disability. Treatment of IS is based on reperfusion methods, thrombolysis and mechanical thrombectomy (MT). However, there are significant limitations in their implementation and success. Also, there is a mismatch between successful recanalization of the blood vessel, recovery of the neurological status as well as treatment outcome. Precisely for these reasons, there is a need for a better understanding of pathophysiology events in the acute IS and for the development of new therapeutic procedures that would include neuroprotection, modification of the inflammatory response and preservation of the integrity of the blood-brain barrier. Acute IS occurs as a result of a blood vessel blockage, which leads to ischemic damage to the brain parenchyma. It causes an early inflammatory response that is extremely complex, involving a large number of inflammatory cytokines whose dynamics and role in the pathophysiology of IS are insufficiently investigated. It is known that inflammatory processes damage the endothelial glycocalyx (EG), a thin luminal layer of the endothelium that has numerous functions such as maintaining the integrity of blood vessels and regulating tone, and itself participates in the inflammatory response. In the brain, EG is a key regulator of the integrity of the blood-brain barrier, and its damage makes the barrier more permeable, which can lead to edema and the passage of potentially harmful substances. Clinical studies have shown that there is a possible relationship between the prognosis of patients with IS and the concentration of EG breakdown products in the peripheral blood. However, the relationship between changes in EG and the inflammatory process in the context of IS, and especially in relation to available treatment methods, remains unclear. The aim of the proposed study is to determine and analyze the dynamics of concentrations of EG degradation products and inflammatory cytokines in patients with acute IS during and after MT. This study would include all adult patients with acute IS who will undergo MT, and the concentrations of EG degradation products and inflammatory cytokines would be determined by the enzyme immunoassay method from peripheral blood and blood samples from the cerebral circulation after reperfusion. The obtained results will be correlated with the collected data on the neurological condition of the patient before and after the intervention, the type and course of the intervention performed, the course and duration of hospital treatment, the occurrence of complications and the outcome of treatment.
- Conditions
- Stroke, Thrombectomy, Endothelial Glycocalyx
- Being tested
- Mechanical thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
The concentrations of EG degradation products and inflammatory cytokines would be determined by the enzymatic immunoabsorption test method from peripheral blood and blood samples from cerebral circulation after reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke patients | MT/ MT + thrombolysis/ thormbolysis only Receives: Procedure: Mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.
To measure and analyze the concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization. Additionally, the concentrations of EG degradation products in a blood sample from the occlusion site after revascularization will be measured and analyzed.
Measured: 24 hours
Cytokine concentrations (IL 6, IL 10)
Measure and analyze cytokine concentrations (IL 6, IL 10) in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Rijeka, University of Rijeka
- Responsible party
- Principal investigator, Marijana Matas, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292974
- Sponsor's protocol ID
- uniri-iz-25-224
- Acronym
- DEGIMT
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DYNAMIC CHANGES OF ENDOTHELIAL GLYCOCALYX AND INFLAMMATORY RESPONSE IN PATIENTS WITH ACUTE STROKE TREATED WITH MECHANICAL THROMBECTOMY
- ClinicalTrials.gov ID
- NCT07292974
- Acronym / sponsor ID
- DEGIMT / uniri-iz-25-224
- Conditions
- Stroke, Thrombectomy, Endothelial Glycocalyx
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Collaborators
- University Hospital Rijeka, University of Rijeka
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 18 Dec 2025 (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.
Ischemic stroke (IS) is one of the leading causes of mortality and disability. Treatment of IS is based on reperfusion methods, thrombolysis and mechanical thrombectomy (MT). However, there are significant limitations in their implementation and success. Also, there is a mismatch between successful recanalization of the blood vessel, recovery of the neurological status as well as treatment outcome. Precisely for these reasons, there is a need for a better understanding of pathophysiology events in the acute IS and for the development of new therapeutic procedures that would include neuroprotection, modification of the inflammatory response and preservation of the integrity of the blood-brain barrier. Acute IS occurs as a result of a blood vessel blockage, which leads to ischemic damage to the brain parenchyma. It causes an early inflammatory response that is extremely complex, involving a large number of inflammatory cytokines whose dynamics and role in the pathophysiology of IS are insufficiently investigated. It is known that inflammatory processes damage the endothelial glycocalyx (EG), a thin luminal layer of the endothelium that has numerous functions such as maintaining the integrity of blood vessels and regulating tone, and itself participates in the inflammatory response. In the brain, EG is a key regulator of the integrity of the blood-brain barrier, and its damage makes the barrier more permeable, which can lead to edema and the passage of potentially harmful substances. Clinical studies have shown that there is a possible relationship between the prognosis of patients with IS and the concentration of EG breakdown products in the peripheral blood. However, the relationship between changes in EG and the inflammatory process in the context of IS, and especially in relation to available treatment methods, remains unclear. The aim of the proposed study is to determine and analyze the dynamics of concentrations of EG degradation products and inflammatory cytokines in patients with acute IS during and after MT. This study would include all adult patients with acute IS who will undergo MT, and the concentrations of EG degradation products and inflammatory cytokines would be determined by the enzyme immunoassay method from peripheral blood and blood samples from the cerebral circulation after reperfusion. The obtained results will be correlated with the collected data on the neurological condition of the patient before and after the intervention, the type and course of the intervention performed, the course and duration of hospital treatment, the occurrence of complications and the outcome of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | Procedure: Mechanical thrombectomyMT/ MT + thrombolysis/ thormbolysis only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 18 years with a diagnosis of acute IS confirmed by brain CT or MRI, and to whom MT will be performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical thrombectomyThe concentrations of EG degradation products and inflammatory cytokines would be determined by the enzymatic immunoabsorption test method from peripheral blood and blood samples from cerebral circulation after reperfusion. | Procedure or surgery | Acute stroke patients |
Primary outcome
Concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.
Time frame: 24 hours
To measure and analyze the concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization. Additionally, the concentrations of EG degradation products in a blood sample from the occlusion site after revascularization will be measured and analyzed.
Cytokine concentrations (IL 6, IL 10)
Time frame: 24 hours
Measure and analyze cytokine concentrations (IL 6, IL 10) in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.
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 18 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Thrombectomy, run by Clinical Hospital Centre Zagreb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization. (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 18 Dec 2025.