Clinical trial NCT01894529: Immunological Biomarkers in Patients With Acute Ischemic Stroke
Official title: Clinical Implications of a Panel of Immunological Biomarkers in Patients With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: ischemic stroke
immune biomarkers
stroke-associated infection
functional outcome
prediction
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-07-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive immune score for favorable outcome
timeFrame: 90 +-15 days after onset of symptoms
measure: Predictive immune score for stroke associated infection
timeFrame: 7 days after onset of symptoms
Secondary outcomes:
measure: Predictive immune score for ischemic progression
timeFrame: 7 days after onset of symptoms
measure: Predictive immune score for functional outcome over the entire mRS
timeFrame: 90 +-15 days after onset of symptoms
measure: Localization and stroke volume analysis
timeFrame: SAI within 7 days and neurological outcome after 3 months after onset of symptoms
measure: Insular cortex involvement and infarct volume
timeFrame: SAI within 7 days and and on the neurological outcome after 3 months
measure: Infection and functional outcome after ischemic stroke
timeFrame: SAI within 7 days after onset of symptoms and neurological outcome after 3 months
measure: Thrombolysis, immune biomarkers and SAI
timeFrame: SAI within 7 days after onset of symptoms
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona
Study officials:
affiliation: Functional Unit of Cerebrovascular Diseases (Hospital Clínic of Barcelona), IDIBAPS and University of Barcelona Barcelona, Spain
name: Angel Chamorro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: