Ischemic StrokeNCT01894529
Immunological Biomarkers in Patients With Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, immune biomarkers, stroke-associated infection, functional outcome, prediction
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 +-15 days after onset of symptoms
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.
Measured: 7 days after onset of symptoms
Secondary outcomes (6)
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.
Measured: 7 days after onset of symptoms
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
Measured: 90 +-15 days after onset of symptoms
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
Measured: SAI within 7 days and neurological outcome after 3 months after onset of symptoms
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
Measured: SAI within 7 days and and on the neurological outcome after 3 months
Infection and functional outcome after ischemic stroke
To assess the independent effect of SAI over the functional outcome at 3 months
Measured: SAI within 7 days after onset of symptoms and neurological outcome after 3 months
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
Measured: SAI within 7 days after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJan 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Angel Chamorro, M.D., Ph.D., Hospital Clinic of Barcelona
- Investigators
- Angel Chamorro, MD, PhD, Principal investigator, Functional Unit of Cerebrovascular Diseases (Hospital Clínic of Barcelona), IDIBAPS and University of Barcelona Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894529
- Sponsor's protocol ID
- PI09/1313
- Status last verified
- Apr 2015
- First submitted
- 4 Jul 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of a Panel of Immunological Biomarkers in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01894529
- Acronym / sponsor ID
- PI09/1313
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, immune biomarkers, stroke-associated infection, functional outcome, prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- ischemic stroke*
- stroke onset within 6h*
- treated with systemic or intraarterial thrombolysis*
- minimum severity in the NIHSS of 3*
- age ≥ 18
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
6 secondary outcomes
Predictive immune score for ischemic progression
Time frame: 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
Localization and stroke volume analysis
Time frame: 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
Infection and functional outcome after ischemic stroke
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Chamorro, MD, PhD principal investigator
Functional Unit of Cerebrovascular Diseases (Hospital Clínic of Barcelona), IDIBAPS and University of Barcelona Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive immune score for favorable outcome (time frame: 90 +-15 days after onset of symptoms). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.