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NCT Number: NCT03948802

Evaluation of IL-33 in Patients With the Acute Ischemic Stroke

Aim of the study is to evaluate the usefulness of interleukin 33 in the blood plasma in patients with the acute ischemic stroke of the brain in relation to mode of treatment (thrombolysis, thrombectomy, no treatment), risk factors in correlation with other inflammatory state markers (hsCRP, morphology with smear ). Blood is collected on the first and seventh days of stroke.

The purpose is to clarify utility of IL 33 as a biomarker of acute stroke.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jan Biziel University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University

Bydgoszcz, 86-168, Poland

About this study

Stroke is the third most frequent cause of death in highly developed countries (after heart disease and cancer), the main cause of disability in adults and the second most frequent cause of dementia syndromes. The annual incidence of stroke in the general population is approximately 0.2%. The risk of stroke increases with age.

Globally 15 million people are affected each year and 5.5 million die every year for this reason (20% in 30 days and up to 40% in a year from getting ill). In Poland, the incidence of stroke is around 175/100,000 in men and 125/100 in women.It is assumed that the cause of sudden cerebral insufficiency is mainly the embolism coming from the newly formed wall clot forming at the site of the atherosclerotic plaque rupture.

In recent years, the role of inflammatory factors is associated with the occurrence of severe atherosclerotic complications such as stroke or heart attack. Cytokines are glycoproteins that are released by activated cells of various tissues. They have a significant impact on the inflammation processes, they control all phases of the immune response. Interleukin is one of the cytokine groups. This study aims to find a relationship between level of IL 33 concentration and the size of the stroke and neurological deficit.

Blood will be collected on the first and seventh days of stroke for examination of Il 33, blood morphology and hsCRP

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18
  • Consent on participation
  • Diagnosed Ischemic Stroke

Exclusion criteria

  • Active cancer disease
  • Kidney failure
  • Liver failure
  • Pregnancy
  • Breastfeeding

Treatment and study plan

Interleukine 33 test in blood plasma

Diagnostic Test

ELISA test for Interleukin 33

Primary outcomes

  1. NIHSS The National Institutes of Health Stroke Scale

    Time frame: 7 days

    Score 0-6 gently course of the cerebral stroke more than 6 increased manifestations of the cerebral infarction.Patients will be assessed before and after the trial to compare how each participant improved after given the intervention.

  2. DRAGON scale

    Time frame: 7 days

    Comparison of patients in DRAGON scale on the 1st and the 7th day. DRAGON scale was developed to make early predictions about clinical outcomes for ischemic stroke patients using only information that is available shortly after they arrive at the hospital and before tPA is given. The DRAGON score, especially at the low and high end of the scale, can help predict which patients are likely to have good clinical outcomes and those who are likely to have miserable clinical outcomes even if given tPA. These patients may also be potential candidates for endovascular thrombectomy, though the benefits of this procedure have not yet been demonstrated in the literature.

  3. ASTRAL scale

    Time frame: 1 day

    ASTRAL scale is used in patients with acute ischemic stroke admitted within 24 hours of stroke onset. It can provide additional information on medium-term functional outcome in patients that have suffered acute ischemic stroke, in addition to clinical judgment based on relevant clinical and laboratory variables.It can be used to adjust for functional outcome in multivariate models in acute stroke-related research studies.It can serve as a selection criterion for cohorts in acute stroke-related research studies.

  4. Modified Rankin Scale

    Time frame: 7 days

    Change in disability. mRS can help users determine the degree of disability in patients who have suffered a stroke. mRS assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death

  5. IL 33 and hsCRP concentration

    Time frame: 7 days

    Evaluation of IL 33 and hsCRP concentration, morphology with smear on the first and seventh day.

Sponsors and collaborators

Lead sponsor

Jan Biziel University Hospital No 2 in Bydgoszcz

Other

Registry information

Official study title

Evaluation of Interleukin 33 in Relation to Selected Inflammatory Parameters in Patients With the Acute Ischemic Stroke of the Brain

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
May 14, 2019
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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