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OpenTrials
Completed

NCT Number: NCT01894529

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2013
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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