Immunological Biomarkers in Patients With Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Clinical Implications of a Panel of Immunological Biomarkers in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894529
• Other study ID #: PI09/1313
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: April 28, 2015
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Spain	Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive immune score for favorable outcome	To establish a predictive immune score for functional outcome. Favorable outcome is defined as a modified Rankin Scale (mRS) score of <3 at day 90+-15 after stroke	90 +-15 days after onset of symptoms	No
Primary	Predictive immune score for stroke associated infection	To establish a predictive score for stroke associated infection (SAI) based on immune biomarkers. Stroke associated infection is defined as: body temperature > 37.7ºC and symptoms of infection (cough, dyspnea, pleuritic pain, dysuria), or leukocytosis >11000, leukopenia <4000, pulmonary infiltrates in chest X-ray or positive cultures for a pathogen.	7 days after onset of symptoms	No
Secondary	Predictive immune score for ischemic progression	To establish a predictive score for ischemic progression based in a panel of immune biomarkers. Ischemic progression is defined as an increase of =4 points in the National Institutes of Health Stroke Scale(NIHSS) score in the absence of bleeding in the CT scan.	7 days after onset of symptoms	No
Secondary	Predictive immune score for functional outcome over the entire mRS	To establish a predictive score for functional outcome based in a panel of immune biomarkers and using shift analysis of the entire mRS	90 +-15 days after onset of symptoms	No
Secondary	Localization and stroke volume analysis	To investigate the influence of the localization and stroke volume on the occurrence of a stroke associated infection and on neurological outcome	SAI within 7 days and neurological outcome after 3 months after onset of symptoms	No
Secondary	Insular cortex involvement and infarct volume	To investigate the influence of insular cortex involvement and infarct volume on the occurrence of a SAI and on the neurological outcome after 3 months	SAI within 7 days and and on the neurological outcome after 3 months	No
Secondary	Infection and functional outcome after ischemic stroke	To assess the independent effect of SAI over the functional outcome at 3 months	SAI within 7 days after onset of symptoms and neurological outcome after 3 months	No
Secondary	Thrombolysis, immune biomarkers and SAI	To assess the effect of thrombolytic treatment over changes in the immune biomarker panel and over the occurrence of SAI	SAI within 7 days after onset of symptoms	No

External Links

•   Home page of the Functional Unit of Cerebrovascular Diseases, Hospital Clinic of Barcelona