Immunological Biomarkers in Patients With Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischemic stroke

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

No interventions assigned to this group

Healthy subjects

Age-matched individuals free of acute neurological injury

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ischemic stroke\*
* stroke onset within 6h\*
* treated with systemic or intraarterial thrombolysis\*
* minimum severity in the NIHSS of 3\*
* age ≥ 18
* consent by the patient or the legal representative

* These items do not apply for healthy subjects.

Exclusion Criteria

* intracranial hemorrhage
* signs of infection at admission
* use of antibiotics, immunosuppressors or corticosteroids in the previous 3 months
* significant disability (mRS\>2) before index stroke

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes