Prognostic Accuracy of ST2 Dynamics in Ischemic Stroke Outcome (ST2ROKE)

July 26, 2021 updated by: Ana Sruk, General Hospital Sveti Duh

Prognostic Accuracy of Suppression of Tumorigenicity 2 Dynamics in Ischemic Stroke Outcome

Early outcome prediction after ischemic stroke (IS) is of great importance. Prognosis is usually based on clinical variables and neuroradiological findings while serum biomarkers may contribute to prognostic accuracy. Inflammatory biomarker Suppression of Tumorigenicity 2 (ST2) has been shown as promising in IMU outcome predicting. The relationship between ST2 serum values and IS severity is not fully clarified. The proposed hypothesis is that earlier releasing and higher ST2 serum concentrations will be associated with a worse IS outcome. In this prospective and observational study 20 patients with IS will be included and followed. The primary outcome is functional outcome according to the modified Ranking scale at 90 days. In case of hypothesis confirmation, theoretical contribution will be in a better understanding of pathophysiological changes in acute phase of IS, while the clinical purpose is to improve the prognostic procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The following data will be collected for all participants: 1. concentration of ST2 biochemical markers, 2. concentration of routine biochemical and hematological tests, 3. prognostic indices of PNI and GPS, 3. sex, 4. age, 5. body weight, 6. body visa, 7. body mass index (BMI), 8. NIHSS, 9. volume of brain infarction, 10. exact time of onset of symptoms, 11. smoking, 12. excessive alcohol drinking, 13. drug abuse, 14. arterial hypertension, 16. atrial fibrillation, 17. presence of cardiac valve, 18. dyslipidemia, 19. diabetes, 20. coronary disease, 21. liver dysfunction, 22. renal dysfunction, 23. peripheral arterial disease, 24. pre-existing stroke / transient ischemic attack, 25. positive family history, 26. complication of IS, 27. etiology of IS according to TOAST (criteria Trial of Org 10172 in Acute Stroke Treatment) criteria, 28. localization of MU according to OCSP (Oxfordshire Community Stroke Project) projects. Procedures: Laboratory parameters will be measured at seven time points, monitored once daily for six consecutive days, and will include: complete blood count, glucose concentration, sodium, urea, creatinine, C - reactive protein, total and direct bilirubin, total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, urate, total protein, albumin, eGFR (estimated glomerular filtration rate) and alanine aminotransferase enzyme activities, aspartate aminotransferase and gamma-glutamyl transpeptidase. The prognostic indices of PNI (formula that includes albumin and leukocyte count) and GPS (formula that includes CRP and albumin) will be calculated. The size of the IS will be analyzed on the basis of computed tomography (CT) of the brain and CT of the brain volumetry according to Pullicino formulas, in patients who will undergo brain CT initially and at least 20-24 hours apart. The IS classification will enforce the use of the TOAST and OCSP criteria. The severity of IS will be clinically assessed using the NIHSS scale at hospital admissions and during each subsequent point in the study timeline. Stroke outcomes will be assessed using mRS on day 6 and day 90 (+/- 7 days) with a comparison of disability on the same rating scale before hospitalization. Sampling will be done during regular business hours and on duty (0-24 hours). Blood will be drawn by the nurse / technician from the ante-cubital vein according to EFML-COABIOCLI guidelines. From the remaining blood samples routinely taken as part of the patient's regular treatment, concentrations of biochemical markers will be determined. In addition, at those time points (up to 6) at which blood is not excluded during laboratory processing for laboratory testing, this will be done for the purposes of this research. The maximum amount of additionally excluded blood for the purposes of this study will therefore be 48 mL. Analysis of routine laboratory parameters will be performed immediately after sampling. Part of the serum will be stored at -20 ° C for subsequent analysis of the concentration of the biochemical marker ST2. Laboratory parameters will be determined by the enzyme linked immunosorbent assay method on an automatic analyzer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Sveti Duh University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population will be patients with ischemic stroke. The available population to be sampled will be patients with ischemic stroke admitted to the Neurology Department with a confirmed diagnosis of ischemic stroke by two experienced neurologists

Description

Inclusion Criteria:

  • onset of symptoms within 24 hours, initial NIHSS≥8 including patients with major blood vessel occlusion who will not be transferred for intervention (due to insufficient collateral, demarcated infarction or other reasons) and consent of the patient or legal representative or guardian

Exclusion Criteria:

  • unknown time of onset of symptoms, duration of symptoms longer than 24 hours, conditions of patients in which, according to the responsible specialist neurologist, additional blood sampling could have an adverse effect on the outcome of the disease, administration of thrombolytic therapy and the presence of the following associated conditions: myocardial infarction, heart failure, malignancy, immune disease, severe infection and pregnancy. The study would exclude subjects diagnosed with transient ischemic attack, MU-like conditions, urgently transferred to another institution for invasive treatment, and patients with MU caused by rare diseases (eg, Fabry's disease, dissections, coagulopathies, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ischemic stroke patients
20 patients with ischemic stroke, onset within 24 hours, NIHSS≥8
Diagnostic test: measurement of serum ST2 concentrations in serum of patients with acute, ischemic stroke
7 measurements of serum ST2 concentrations from day 0 to day 6, modified Rankin scale before, 6th and 90th day, NIHSS from day 0 to day 6 and 90, TOAST and OCSP classifications

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
functional outcome according to the modified Rankin scale
Time Frame: after 90 days:
0-1 good outcome and 2-6 poor outcome
after 90 days:

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: after 90 days
all-cause
after 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital Sveti Duh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Sruk, MD, GH Sveti Duh, Zagreb, Croatia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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