Immunological Biomarkers in Patients With Acute Ischemic Stroke

Completed

Phase N/A Results N/A

Trial Description

Stroke is accompanied by local inflammatory response and systemic immunosuppression. Immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis.
This prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes.
The identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.

Detailed Description

Stroke is accompanied by local inflammatory response and systemic immunosuppression. Immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis.
This prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes. The immune biomarkers will be assessed at admission, at day 1 after admission and at day 90. The assessed immune biomarker panel includes:
- Serum cortisol levels.
- Serum interleukin (IL)-10 levels.
- Proportion of circulating B lymphocytes (CD3-CD19+ cells).
- Monocyte surface expression of TLR4, HLA-DR, CD86, and VLA-4.
- Ex - vivo production of tumor necrosis factor (TNF)-α in monocytes after stimulation with LPS.
- Proportion of each of the circulating monocyte subpopulations (CD14highCD16-, CD14highCD16+, and CD14dimCD16+).
The identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with an ischemic stroke admitted within 6 hours of symptom onset, with a minimum severity in the NIHSS of 3 and treated with systemic or intraarterial thrombolysis and age-matched subjects free of acute neurological injury.

Outcomes

Type Measure Time Frame Safety Issue
Primary Predictive immune score for favorable outcome 90 +-15 days after onset of symptoms No
Primary Predictive immune score for stroke associated infection 7 days after onset of symptoms No
Secondary Predictive immune score for ischemic progression 7 days after onset of symptoms No
Secondary Predictive immune score for functional outcome over the entire mRS 90 +-15 days after onset of symptoms No
Secondary Localization and stroke volume analysis SAI within 7 days and neurological outcome after 3 months after onset of symptoms No
Secondary Insular cortex involvement and infarct volume SAI within 7 days and and on the neurological outcome after 3 months No
Secondary Infection and functional outcome after ischemic stroke SAI within 7 days after onset of symptoms and neurological outcome after 3 months No
Secondary Thrombolysis, immune biomarkers and SAI SAI within 7 days after onset of symptoms No

Biospecimen Retention:Samples Without DNA - Whole blood, serum and plasma.

Sponsors