Actively Recruiting
Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control
Led by Hospices Civils de Lyon · Updated on 2026-04-03
77
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
F
Fondation de France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large arteries, mainly carotid, is involved in about 20% of cases. After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography. The composition of the plaque, showing its vulnerability, is associated with embolic risk and stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo the inflammation of the plaque, its embolic consequences or the mechanical stress it undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile (mi RNA). These different modalities must be combined in order to increase the efficiency. Based on these encouraging results, the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability. Performance evaluation will allow us to choose secondarily the most relevant association. The investigator propose, as a first step, to make a case-control study with these methods, the cases are patients who had an ischemic stroke (authenticated by both the clinical exam and brain MRI) on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke. This study is a cross-sectional study because it simultaneously measures the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque. Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50% caliber constriction according to NASCET criteria. (North American Symptomatic Carotid Endarterectomy Trial).
CONDITIONS
Official Title
Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Carotid stenosis of 50% or greater based on NASCET criteria
- For cases: ischemic stroke on the same side as carotid stenosis confirmed by MRI or CT within the past month with no other stroke causes
- For controls: no clinical or MRI evidence of recent stroke
- Signed informed consent form
- Affiliated to a social security system or equivalent
You will not qualify if you...
- Modified Rankin scale greater than 3
- Stroke or transient ischemic attack on the same side more than 1 month ago
- History of same-side carotid surgery, cervical radiation, carotid occlusion, or intracranial stenosis
- Risk of arterial thromboembolic events
- Renal failure with creatinine clearance less than 50 ml/min
- Contraindication to ultrasound contrast agent (sonovue)
- Contraindication to MRI or gadolinium contrast
- Unable to sign informed consent
- Unable to undergo study procedures (e.g., claustrophobia)
- Serious co-morbid illness or dementia
- Neurological disease unrelated to carotid disease
- Pregnancy, breastfeeding, or risk of pregnancy
- Adult under reinforced guardianship or legal guardianship
- Patient does not understand French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospices Civils de Lyon - Service de radiologie
Bron, France, 69500
Actively Recruiting
Research Team
P
Philippe DOUEK, MD
CONTACT
A
Adeline MANSUY, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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