Clinical trial NCT03948802: Evaluation of IL-33 in Patients With the Acute Ischemic Stroke
Official title: Evaluation of Interleukin 33 in Relation to Selected Inflammatory Parameters in Patients With the Acute Ischemic Stroke of the Brain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Interleukin 33
ASTRAL
DRAGON
NIHSS
Lead sponsor: Jan Biziel University Hospital No 2 in Bydgoszcz
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with ischemic stroke

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: NIHSS The National Institutes of Health Stroke Scale
timeFrame: 7 days
measure: DRAGON scale
timeFrame: 7 days
measure: ASTRAL scale
timeFrame: 1 day
measure: Modified Rankin Scale
timeFrame: 7 days
measure: IL 33 and hsCRP concentration
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Jan Biziel University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Study officials:
affiliation: Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
name: Paweł Sokal
role: PRINCIPAL_INVESTIGATOR
References: