- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607031
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
---|---|
ischemic stroke patients
20 patients with ischemic stroke, onset within 24 hours, NIHSS≥8
|
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
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
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
Investigators
- 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)
September 10, 2019
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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