Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control (ACABII)
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|ClinicalTrials.gov Identifier: NCT02748941|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : January 18, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis||Device: HITS quantification, Ultrasound examinations, High Resolution MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||January 12, 2017|
|Estimated Primary Completion Date :||February 12, 2020|
|Estimated Study Completion Date :||February 12, 2020|
|Experimental: symptomatic and asymptomatic patients||
Device: HITS quantification, Ultrasound examinations, High Resolution MRI
Simultaneously measure the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque
Description of different modalities:
High Resolution MRI:
mi-RNA identification and quantification
- Number of HITS per hour in doppler ultrasonography [ Time Frame: Day 1 ]
- Ulceration > 2 mm presence in doppler ultrasonography [ Time Frame: Day 1 ]
- GSM (Gray Scale Median) quantification in doppler ultrasonography [ Time Frame: Day 1 ]
- CEUS (Contrast Enhanced UltraSound ) [ Time Frame: Day 1 ]signal intensity amplification quantification and Ulceration > 2 mm
- hemorrhage intra-plaque présence in HR MRI [ Time Frame: Day 1 ]
- large lipid-rich necrotic core présence in HR MRI [ Time Frame: Day 1 ]
- ulceration or cap rupture présence in HR MRI [ Time Frame: Day 1 ]
- hemorrhage intra-plaque [ Time Frame: Day 1 ]Compare the results of each modality for pathological analysis of the surgical equipment.
- large lipid-rich necrotic core [ Time Frame: Day 1 ]Compare the results of each modality for pathological analysis of the surgical equipment.
- ulceration or cap rupture [ Time Frame: Day 1 ]Compare the results of each modality for pathological analysis of the surgical equipment.
- shear stresses (Pa) on the surface of the plaque [ Time Frame: Day 1 ]Quantification of the shear stresses (Pa) on the surface of the plaque with an analysis of hemodynamic environment using fluid dynamics mathematical models based on data collected by MRI.
- mi-RNA identification [ Time Frame: Day 1 ]Identification of circulating mi-RNA specific to unstable atherosclerotic plaque by RT-PCR and comparison between case and control
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748941
|Contact: Stéphane LUONG, MD||(0)4 27 85 77 66 ext +33||stéphane.firstname.lastname@example.org|
|Contact: Adeline MANSUY, CRA||(0)4 72 11 5225 ext +email@example.com|
|Hospices Civils de Lyon - Service de radiologie||Recruiting|
|Bron, France, 69500|
|Contact: Stéphane Luong, MD 4 27 85 77 66 ext +33 firstname.lastname@example.org|
|Contact: Adeline MANSUY 4 72 11 52 25 ext +33 email@example.com|
|Principal Investigator: Stéphane Luong, MD|
|Sub-Investigator: Laura MECHTOUFF, MD|