Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04607031 |
Other study ID # |
ST2 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 10, 2019 |
Est. completion date |
March 31, 2021 |
Study information
Verified date |
July 2021 |
Source |
General Hospital Sveti Duh |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
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.