Immunological Biomarkers in Patients With Acute Ischemic Stroke

Hospital Clinic of Barcelona

Status: Completed

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01894529

PI09/1313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

Ischemic stroke

Description:

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

Healthy subjects

Description:

Age-matched individuals free of acute neurological injury