Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control

NCT ID: NCT02748941

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-12
• Study Completion Date: 2026-02-12

Brief Summary

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

Carotid Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

symptomatic and asymptomatic patients

Group Type: EXPERIMENTAL

HITS quantification, Ultrasound examinations, High Resolution MRI

Intervention Type: DEVICE

Simultaneously measure the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque

Description of different modalities:

HITS quantification

Ultrasound examinations:

• Ulceration >2 mm
• Plaque thickness
• GSM: computer analysis after normalization of most informative longitudinal view (image with maximum plaque area) using Photoshop
• CEUS: plaque vascularization detection after bolus injection of SONOVUE on a video recording from the injection of the contrast (Vuebox - Bracco imaging)

High Resolution MRI:

• Stenosis severity, intraplaque hemorrhage, large lipid-rich necrotic core, ulceration or cap rupture and Brain MRI will be evaluated
• Quantification of shear stresses (Pa) on the surface of the plaque

mi-RNA identification and quantification

Interventions

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:

HITS quantification

Ultrasound examinations:

• Ulceration >2 mm
• Plaque thickness
• GSM: computer analysis after normalization of most informative longitudinal view (image with maximum plaque area) using Photoshop
• CEUS: plaque vascularization detection after bolus injection of SONOVUE on a video recording from the injection of the contrast (Vuebox - Bracco imaging)

High Resolution MRI:

• Stenosis severity, intraplaque hemorrhage, large lipid-rich necrotic core, ulceration or cap rupture and Brain MRI will be evaluated
• Quantification of shear stresses (Pa) on the surface of the plaque

mi-RNA identification and quantification

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation de France

OTHER

Sponsor Role: collaborator

Bracco Imaging S.p.A.

INDUSTRY

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Service de radiologie

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe DOUEK, MD

Role: CONTACT

philippe.douek@chu-lyon.fr

(0)472357233 ext. +33

Adeline MANSUY, CRA

Role: CONTACT

adeline.mansuy@chu-lyon.fr

(0)4 72 11 5225 ext. +33

Facility Contacts

Philippe DOUEK, MD

Role: primary

philippe.douek@chu-lyon.fr

0472357233 ext. +33

Adeline MANSUY

Role: backup

adeline.mansuy@chu-lyon.fr

4 72 11 52 25 ext. +33

Other Identifiers

69HCL15_0458

Identifier Type: -

Identifier Source: org_study_id