Immunological Biomarkers in Patients With Acute Ischemic Stroke

April 28, 2015 updated by: Angel Chamorro, M.D., Ph.D., Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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
Healthy subjects
Age-matched individuals free of acute neurological injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive immune score for favorable outcome
Time Frame: 90 +-15 days after onset of symptoms
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
Predictive immune score for stroke associated infection
Time Frame: 7 days after onset of symptoms
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive immune score for ischemic progression
Time Frame: 7 days after onset of symptoms
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
Predictive immune score for functional outcome over the entire mRS
Time Frame: 90 +-15 days after onset of symptoms
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
Localization and stroke volume analysis
Time Frame: SAI within 7 days and neurological outcome after 3 months after onset of symptoms
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
Insular cortex involvement and infarct volume
Time Frame: SAI within 7 days and and on the neurological outcome after 3 months
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
Infection and functional outcome after ischemic stroke
Time Frame: SAI within 7 days after onset of symptoms and neurological outcome after 3 months
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
Thrombolysis, immune biomarkers and SAI
Time Frame: SAI within 7 days after onset of symptoms
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Angel Chamorro, MD, PhD, Functional Unit of Cerebrovascular Diseases (Hospital Clínic of Barcelona), IDIBAPS and University of Barcelona Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI09/1313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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