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

NCT ID: NCT07292974

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2030-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Thrombectomy Endothelial Glycocalyx

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute stroke patients

MT/ MT + thrombolysis/ thormbolysis only

Mechanical thrombectomy

Intervention Type 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.

Interventions

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Mechanical thrombectomy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Rijeka

OTHER

Sponsor Role collaborator

University of Rijeka

OTHER

Sponsor Role collaborator

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Marijana Matas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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uniri-iz-25-224

Identifier Type: -

Identifier Source: org_study_id