Clinical trial NCT03812666: Search for Biomarkers of Infection and Inflammation in Patients With Acute Stroke.
Official title: Inflammatory Biomarkers In Stroke - Discovery Phase
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke, Acute
Pneumonia, Bacterial
Keywords: Stroke
Pneumonia
Biomarkers
Infection
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
First posted: 2019-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients admitted to Örebro University hospital will be consecutively offered enrollement. The sample is weighted to include more patients with severe stroke (defined as NIHSS ≥ 11) than with moderate (NIHSS ≤10 and ≥ 6) or mild (NIHSS ≤5) stroke. The purpose of this is to ensure that a high proportion of participants will contract pneumonia since patients with a more severe stroke have a higher risk of pneumonia.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Novel biomarkers of pneumonia
timeFrame: The day before pneumonia onset.
measure: A combined clinical and molecular biological signature for early detection of pneumonia
timeFrame: The day before pneumonia onset.
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
state: Örebro Län
Study officials:
affiliation: Region Örebro County
name: Jakob Ström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: