Informations générales (source: ClinicalTrials.gov)
(ACABII)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2017
février 2026
05 avril 2025
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Service de radiologie - 69500 - Bron - France | Philippe DOUEK, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Carotid stenosis ≥ 50% NASCET
- Case: ipsilateral carotid stenosis stroke, certified by MRI or CT in the preceding
month, with no others causes of stroke
- Control: no clinical sign or MRI hint for a recent stroke
- Signed informed consent form
- Patient affiliated to a social security system or equivalent
- Carotid stenosis ≥ 50% NASCET
- Case: ipsilateral carotid stenosis stroke, certified by MRI or CT in the preceding
month, with no others causes of stroke
- Control: no clinical sign or MRI hint for a recent stroke
- Signed informed consent form
- Patient affiliated to a social security system or equivalent
- Modified Rankin scale > 3
- Homolateral stroke or TIA > 1 month
- Medical history of homolateral carotid surgery, cervical radiation, carotid
occlusive, homolateral intracranial stenosis, risk of developing arterial
thromboembolic events
- Renal failure (creatinine clearance < 50 ml/min)
- Contraindication to ultrasound (sonovue)
- Contraindication to MRI and its contrast media (Gadolinium)
- Inability to sign informed consent
- Inability to undergo any of the technics (claustrophobia...)
- Serious co-morbid disease, dementia
- Neurological disease with no carotid disease
- Risk of pregnancy or pregnancy or breastfeeding
- Adult under reinforced guardianship or legal guardian
- Patient not understanding French