Ischemic StrokeNCT03948802
Evaluation of IL-33 in Patients With the Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
Trial 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 ). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Interleukine 33 test in blood plasma
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 6 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with ischemic stroke
Who may be able to join
- Age over 18
- Consent on participation
- Diagnosed Ischemic Stroke
Who cannot join
- Active cancer disease
- Kidney failure
- Liver failure
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jan Biziel University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, 86-168
About this study
Official title: Evaluation of Interleukin 33 in Relation to Selected Inflammatory Parameters in Patients With the Acute Ischemic Stroke of the Brain
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.
Read the 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
- Conditions
- Ischemic Stroke
- Being tested
- Interleukine 33 test in blood plasma
- Keywords
- Ischemic Stroke, Interleukin 33, ASTRAL, DRAGON, NIHSS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukine 33 test in blood plasmaDiagnostic test
ELISA test for Interleukin 33
| Study group | Role | What they receive |
|---|---|---|
| STROKE GROUP | Cerebral ischemic stroke patients treated. Receives: Diagnostic Test: Interleukine 33 test in blood plasma | |
| CONTROL GROUP | Ambulatory healthy patients Receives: Diagnostic Test: Interleukine 33 test in blood plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS The National Institutes of Health Stroke Scale
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.
Measured: 7 days
DRAGON scale
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.
Measured: 7 days
ASTRAL scale
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.
Measured: 1 day
Modified Rankin Scale
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
Measured: 7 days
IL 33 and hsCRP concentration
Evaluation of IL 33 and hsCRP concentration, morphology with smear on the first and seventh day.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
- Investigators
- Paweł Sokal, Principal investigator, Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948802
- Sponsor's protocol ID
- JBUH-NN-STROKE-IL33
- Status last verified
- Aug 2025
- First submitted
- 10 May 2019
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interleukin 33 in Relation to Selected Inflammatory Parameters in Patients With the Acute Ischemic Stroke of the Brain
- ClinicalTrials.gov ID
- NCT03948802
- Acronym / sponsor ID
- JBUH-NN-STROKE-IL33
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Interleukin 33, ASTRAL, DRAGON, NIHSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jan Biziel University Hospital No 2 in BydgoszczUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STROKE GROUP | – | Diagnostic Test: Interleukine 33 test in blood plasmaCerebral ischemic stroke patients treated. |
| CONTROL GROUP | – | Diagnostic Test: Interleukine 33 test in blood plasmaAmbulatory healthy patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ischemic stroke
Key inclusion criteria (3 listed)
- Age over 18
- Consent on participation
- Diagnosed Ischemic Stroke
Key exclusion criteria (5 listed)
- Active cancer disease
- Kidney failure
- Liver failure
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukine 33 test in blood plasmaELISA test for Interleukin 33 | Diagnostic test | CONTROL GROUP, STROKE GROUP |
Primary outcome
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.
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Sokal principal investigator
Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS The National Institutes of Health Stroke Scale (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.