IBIS: Search for Biomarkers of Infection and Inflammation in Patients With Acute Stroke.

Sponsor

Jakob Ström (Other)

Overall Status

Recruiting

CT.gov ID

NCT03812666

Collaborator

Örebro University, Sweden (Other)

200

Enrollment

Location

29.5

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. Patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Pneumonia, Bacterial

Detailed Description

Rationale: Stroke is one of the leading causes of death globally, and infections after stroke contribute to a large part of the stroke-related mortality. The current study, which has a prospective, observational design, constitutes the second phase out of four in the Inflammatory Biomarkers In Stroke (IBIS) project, of which the overall goal is to enable early treatment of post-stroke infections.

Aim: To develop a combined clinical and molecular biological signature for early detection of pneumonia in patients with stroke.

Design: Prospective nested case control study

Methods:Patients (n=200) with acute stroke will be monitored with clinical examinations for ten days and by daily blood samples for seven days. When cases of pneumonia have been established, samples and examination results from days preceding overt pneumonia will be compared to samples from similar patients that did not develop pneumonia.

Outcome: Using proteomic and metabolomic methods, novel markers of upcoming pneumonia after stroke will be sought. Such laboratory markers will be combined with current biomarkers (such as C-reactive protein and procalcitonin) and data from clinical examinations, with the aim of constructing a biological signature that enables early detection of pneumonia.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Inflammatory Biomarkers In Stroke - Discovery Phase

Actual Study Start Date :

Jan 15, 2019

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Severe stroke Patients with severe (defined as NIHSS score of > 10) acute stroke, either ischemic or hemorrhagic. (n= 150)
Moderately stroke Patients with moderately severe (defined as NIHSS score of > 5 but < 11) acute stroke, either ischemic or hemorrhagic. (n= 25)
Mild stroke Patients with mild (defined as NIHSS score of <6) acute stroke, either ischemic or hemorrhagic. (n= 25)

Outcome Measures

Primary Outcome Measures

Novel biomarkers of pneumonia [The day before pneumonia onset.]
The study will analyze a broad expanse of potential biomarkers, including known markers of infection such as c-reactive protein, procalcitonin and increased respiratory frequency as well as novel markers that will be pursued using proteomic and metabolomic methods. Those that are significantly associated with upcoming pneumonia will be selected. Biomarkers will be evaluated by the area under the curve for the receiver operating characteristic (AUC-ROC).
A combined clinical and molecular biological signature for early detection of pneumonia [The day before pneumonia onset.]
By combining novel (found using proteomic and metabolomic methods) and current biomarkers (such as c-reactive protein, procalcitonin and increased respiratory frequency) with data from clinical examinations, a biological signature that enables early detection of pneumonia will be constructed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptoms and radiology consistent with acute cerebral infarction or atraumatic intracerebral hemorrhage.
National Institutes of Health Stroke Scale (NIHSS) ≤5; mild stroke (n=25), NIHSS ≤10 and ≥ 6; moderate stroke (n=25) or NIHSS ≥ 11; severe stroke (n=150)
Onset of symptoms less than 48 hours before first study blood sampling.

Exclusion Criteria:

Symptoms and radiology consistent with acute cerebral infarction but full reversal of symptoms within 24 hours of onset. (i.e. transient ischemic attack, TIA)
Hemoglobin less than 90 g/l.
Ongoing inflammatory disease, such as rheumatoid arthritis or active inflammatory bowel disease.
Inability to undergo MRI scan (only patients with NIHSS ≤10 will be excluded by this criteria)