Investigating the role of ficolin-2 in carotid stenosis and brain inflammation

Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2

This study is testing if a specific biomarker can help identify dangerous plaque in the carotid artery of patients who have had a mini-stroke or stroke, to see if they might benefit from a procedure to improve blood flow.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 1 site (Bron)
• Trial ID: NCT05850247 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the relationship between plaque composition in carotid artery stenosis and the risk of ischemic stroke, focusing on the biomarker ficolin-2. It will involve patients who have experienced a transient ischemic attack, retinal artery occlusion, or ischemic stroke, and who have significant carotid stenosis. The study will utilize [18F]DPA-714 PET/MRI imaging to assess the state of the plaques and their inflammatory status. By identifying vulnerable plaques, the trial seeks to determine which patients may benefit from carotid revascularization.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over who have experienced a recent transient ischemic attack, retinal artery occlusion, or ischemic stroke and have significant carotid stenosis.

Not a fit: Patients with inflammatory or autoimmune diseases, active malignancies, or recent major surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification of patients at high risk for stroke, allowing for timely and targeted interventions.

How similar studies have performed: While the specific approach of using ficolin-2 as a biomarker in this context is novel, there is existing evidence supporting the role of the complement system in atherosclerosis.

Eligibility criteria

Inclusion Criteria:

* Patients 18 years or over,
* Signed written informed consent before any study specific intervention,
* Probable ipsilateral transient ischemic attack (TIA - which involve a focal speech/language, motor or visual deficit referable to the distribution of a carotid artery and lasting less than 48 hours from the onset) OR retinal artery occlusion ≤ 48h OR ischemic stroke ≤ 48h from the onset,
* Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR angiography, CT angiography, catheter angiography) performed after index TIA or ischemic stroke
* No other identified cause of TIA, ischemic stroke or retinal artery occlusion,

Exclusion Criteria:

* Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction or major surgery within the previous 30 days of index hospitalization according to the investigator,
* Patients with severe renal insufficiency (estimated GFR \< 30 ml/min at inclusion or known dialysis),
* Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according to the investigator's judgment,
* Patients with modified Rankin score greater than 3,
* Patients currently enrolled in another clinical trial including investigational medicinal products,
* Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout the study,
* Patient without health coverage,
* Patient under legal protection

Where this trial is running

Bron

• Service de Neurologie vasculaire / CarMeN U1060 INSERM Hôpital Neurologique Pierre Wertheimer - GHE — Bron, France (Recruiting)

Study contacts

• Principal investigator: Laura MECHTOUFF — Service de Neurologie vasculaire / CarMeN U1060 INSERM
• Study coordinator: Laura MECHTOUFF

Conditions CAROTID STENOSIS