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

Stroke, Acute Clinical Trial

— IBIS  

Official title:

Inflammatory Biomarkers In Stroke - Discovery Phase

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03812666
• Other study ID #: 247991
• Secondary ID: 2018/288
• Status: Active, not recruiting
• Start date: January 15, 2019
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial
• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro	Örebro Län

Sponsors (2)

Lead Sponsor	Collaborator
Jakob Ström	Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Novel biomarkers of pneumonia	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).	The day before pneumonia onset.
Primary	A combined clinical and molecular biological signature for early detection of pneumonia	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.	The day before pneumonia onset.