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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identification of Biomarkers in Ischemic Stroke - Clinical Trial

NCT04253275

Stroke, Ischemic Stroke Hemorrhagic

COMPLETED NA

Biomarkers of Acute Stroke in Clinic

NCT03897478

Ischemic Stroke Ischemia Atrial Fibrillation +14 more

UNKNOWN

Evaluation of IL-33 in Patients With the Acute Ischemic Stroke

NCT03948802

Ischemic Stroke

COMPLETED

Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)

NCT01264549

Ischemic Stroke

COMPLETED NA

Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS

NCT06549972

Ischemic Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Pneumonia, Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe stroke

Patients with severe (defined as NIHSS score of \> 10) acute stroke, either ischemic or hemorrhagic. (n= 150)

No interventions assigned to this group

Moderately stroke

Patients with moderately severe (defined as NIHSS score of \> 5 but \< 11) acute stroke, either ischemic or hemorrhagic. (n= 25)

No interventions assigned to this group

Mild stroke

Patients with mild (defined as NIHSS score of \<6) acute stroke, either ischemic or hemorrhagic. (n= 25)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No