ENDOTHELIAL GLYCOCALYX AND INFLAMMATORY RESPONSE CHANGES IN PATIENTS WITH ACUTE STROKE UNDERGOING MECHANICAL THROMBECTOMY

NCT07292974 | Not Yet Recruiting

• 1 other identifier: uniri-iz-25-224
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours

Study Arms (1)

Acute stroke patients

MT/ MT + thrombolysis/ thormbolysis only

Procedure: Mechanical thrombectomy

Interventions

Mechanical thrombectomy PROCEDURE

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.

Acute stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead
• University Hospital Rijeka: collaborator
• University of Rijeka: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share