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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: laura.mechtouff@chu-lyon.fr
• Phone: 4.27.85.67.47

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.