NCT01894529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

July 4, 2013

Last Update Submit

April 28, 2015

Conditions

Ischemic Stroke

Keywords

ischemic strokeimmune biomarkersstroke-associated infectionfunctional outcomeprediction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (6)

  • Predictive immune score for ischemic progression

    7 days after onset of symptoms

  • Predictive immune score for functional outcome over the entire mRS

    90 +-15 days after onset of symptoms

  • Localization and stroke volume analysis

    SAI within 7 days and neurological outcome after 3 months after onset of symptoms

  • Insular cortex involvement and infarct volume

    SAI within 7 days and and on the neurological outcome after 3 months

  • Infection and functional outcome after ischemic stroke

    SAI within 7 days after onset of symptoms and neurological outcome after 3 months

  • +1 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Functional Unit of Cerebrovascular Diseases, Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum and plasma.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Angel Chamorro, MD, PhD

    Functional Unit of Cerebrovascular Diseases (Hospital Clínic of Barcelona), IDIBAPS and University of Barcelona Barcelona, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ángel Chamorro

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

January 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

ES(1)