Actively Recruiting
Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2
Led by Hospices Civils de Lyon · Updated on 2025-02-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Carotid artery stenosis affects about 3% of people aged 60 and over and contributes to 10-20% of ischemic strokes. The risk of stroke is influenced not only by the degree of artery narrowing but also by the type of plaque present. Researchers are studying the role of ficolin-2, a protein involved in the body's immune response, as a potential biomarker to identify vulnerable plaques and brain inflammation in patients with transient ischemic attack or acute ischemic stroke caused by carotid stenosis. The study involves patients with at least 50% carotid artery stenosis who have experienced recent ischemic events. Each participant will undergo a blood test to measure plasma levels of ficolin-2 and a combined positron emission tomography (PET) and magnetic resonance imaging (MRI) scan using the [18F]DPA-714 radiotracer to detect inflammation in the carotid artery plaque and brain. The imaging and blood tests will be performed around day 5 after the ischemic event. Participants will be monitored through these imaging and blood assessments to evaluate the correlation between ficolin-2 levels and inflammation in the brain and carotid artery plaque. Researchers will also analyze MRI data at day 5 and day 15 to observe morphological changes. The main outcome is to understand how ficolin-2 relates to plaque and brain inflammation, which may help identify patients at higher risk of stroke. The study is expected to continue until the end of 2026.
CONDITIONS
Brief Title
Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Signed written informed consent before any study-specific intervention
- Probable ipsilateral transient ischemic attack (TIA) involving speech, motor, or visual deficit lasting less than 48 hours, or retinal artery occlusion within 48 hours, or ischemic stroke within 48 hours from onset
- Atherosclerotic carotid stenosis between 50% and 99% confirmed by imaging after the index event
- No other identified cause of TIA, ischemic stroke, or retinal artery occlusion
You will not qualify if you...
- Inflammatory or autoimmune disease, liver failure, acute or chronic infection, active cancer, recent myocardial infarction or major surgery within 30 days
- Severe kidney failure (estimated GFR less than 30 ml/min) or dialysis
- Contraindication to MRI (such as agitation, claustrophobia, pacemaker, metallic body parts, allergy to gadolinium)
- Modified Rankin score greater than 3
- Currently enrolled in another clinical trial with investigational medicines
- Pregnant, breastfeeding, or of childbearing potential not using effective birth control
- Lack of health insurance coverage
- Under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants undergo [18F]DPA-714 PET/MRI scans of the brain and carotid plaque with gadolinium infusion to assess inflammation related to carotid stenosis.
1 imaging visit on day 5
Duration - 10 days
Participants have additional MRI assessments to evaluate morphological data of the brain and carotid plaque.
1 follow-up imaging visit on day 15
Trial Site Locations
Total: 1 location
1
Service de Neurologie vasculaire / CarMeN U1060 INSERM Hôpital Neurologique Pierre Wertheimer - GHE
Bron, France, 69500
Actively Recruiting
Research Team
L
Laura MECHTOUFF
N
Naoual EL JONHY
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here