Prognostic Accuracy of ST2 Dynamics in Ischemic Stroke Outcome

NCT04607031 | Completed

• 1 other identifier: ST2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; ST2; prognostic accuracy; outcome

Outcome Measures

Primary Outcomes (1)

• functional outcome according to the modified Rankin scale

  0-1 good outcome and 2-6 poor outcome

  after 90 days:

Secondary Outcomes (1)

• all-cause mortality

  after 90 days

Study Arms (1)

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

Interventions

measurement of serum ST2 concentrations in serum of patients with acute, ischemic stroke DIAGNOSTIC_TEST

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

ischemic stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• General Hospital Sveti Duh: lead

Study Sites (1)

Sveti Duh University Hospital

Zagreb, City of Zagreb, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Sruk, MD

  GH Sveti Duh, Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: September 10, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

CR (1)