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

RecruitingPhase 2Ages 18 Years - anyAllHospices Civils de Lyon
NCT05850247 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Carotid artery stenosis is observed in about 3% of ≥ 60 years subjects and accounts for around 10-20% of all ischemic strokes. Beyond the degree of stenosis, plaque composition affects the risk of ischemic stroke. Identification of patients with vulnerable plaques at higher risk of stroke who might benefit from carotid revascularization is crucial. A growing body of evidence suggests that the lectin pathway of the complement system, and especially the ficolin-2, is involved in atherosclerosis. It has been hypothesized that circulating levels of ficolin-2 increase during chronic inflammatory conditions (i.e. growing atherosclerotic plaque) whereas they fall during sub-acute or acute inflammatory conditions (i.e. plaque rupture and acute ischemic stroke) because of consumption (binding to targets). Therefore, ficolin-2 has been proposed as a biomarker informing on the specific state of th

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📋 Eligibility rules (as published)
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
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What it tests

  • [18F]DPA-714 PET/MRI
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Where

1 site
Service de Neurologie vasculaire / CarMeN U1060 INSERM Hôpital Neurologique Pierre Wertheimer - GHE
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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