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

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ClinicalTrials.gov Identifier: NCT03948802
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz

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.


Condition or disease Intervention/treatment
Ischemic Stroke Diagnostic Test: Interleukine 33 test in blood plasma

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

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Interleukin 33 in Relation to Selected Inflammatory Parameters in Patients With the Acute Ischemic Stroke of the Brain
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Group/Cohort Intervention/treatment
STROKE GROUP
Cerebral ischemic stroke patients treated.
Diagnostic Test: Interleukine 33 test in blood plasma
ELISA test for Interleukin 33

CONTROL GROUP
Ambulatory healthy patients
Diagnostic Test: Interleukine 33 test in blood plasma
ELISA test for Interleukin 33




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
For the examination a venous blood is taken up from the elbow vein - 10 ml into the test tube containing 3.2 % solution of sodium citrate, for routine examinations (including the morphology with the smear, hsCRP). The concentration of interleukin 33 is assessed with the Elisa test. Blood is taken twice: in first twenty-four hours and seventh day after the cerebral stroke.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with ischemic stroke
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948802


Contacts
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Contact: Pawel Sokal 48600954415 pawel.sokal@cm.umk.pl
Contact: Paulina Sobieszak-Skura begam@interia.pl

Locations
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Poland
Jan Biziel University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University Recruiting
Bydgoszcz, Poland, 86-168
Contact: Paweł Sokal, Ph.D.    600954415 ext 48    pawel.sokal@cm.umk.pl   
Contact: Paulina Sobieszak-Skura, M.D.    609673792 ext 48    begam@interia.pl   
Principal Investigator: Paulina Sobieszak-Skura, M.D.         
Sponsors and Collaborators
Jan Biziel University Hospital No 2 in Bydgoszcz
Investigators
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Principal Investigator: Paweł Sokal Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
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Responsible Party: Pawel Sokal, Head of Department of Neurosurgery and Neurology, Jan Biziel University Hospital No 2 in Bydgoszcz
ClinicalTrials.gov Identifier: NCT03948802    
Other Study ID Numbers: JBUH-NN-STROKE-IL33
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz:
Ischemic Stroke
Interleukin 33
ASTRAL
DRAGON
NIHSS
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia