Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control

NCT02748941 | Recruiting

• 1 other identifier: 69HCL15_0458
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

unstable/stable atherosclerotic plaque; HITS; GSM; CEUS; HR MRI; mi-RNA

Outcome Measures

Primary Outcomes (7)

• Number of HITS per hour in doppler ultrasonography

  Day 1

• Ulceration > 2 mm presence in doppler ultrasonography

  Day 1

• GSM (Gray Scale Median) quantification in doppler ultrasonography

  Day 1

• CEUS (Contrast Enhanced UltraSound )

  signal intensity amplification quantification and Ulceration \> 2 mm

  Day 1

• hemorrhage intra-plaque présence in HR MRI

  Day 1

• large lipid-rich necrotic core présence in HR MRI

  Day 1

• ulceration or cap rupture présence in HR MRI

  Day 1

Secondary Outcomes (5)

• hemorrhage intra-plaque

  Day 1

• large lipid-rich necrotic core

  Day 1

• ulceration or cap rupture

  Day 1

• shear stresses (Pa) on the surface of the plaque

  Day 1

• mi-RNA identification

  Day 1

Study Arms (1)

symptomatic and asymptomatic patients

EXPERIMENTAL

Device: HITS quantification, Ultrasound examinations, High Resolution MRI

Interventions

HITS quantification, Ultrasound examinations, High Resolution MRI 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

symptomatic and asymptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Fondation de France: collaborator
• Bracco Imaging S.p.A.: collaborator

Study Sites (1)

Hospices Civils de Lyon - Service de radiologie

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Philippe DOUEK, MD

CONTACT

(0)472357233; philippe.douek@chu-lyon.fr

Adeline MANSUY, CRA

CONTACT

(0)4 72 11 5225; adeline.mansuy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 22, 2016
• Study Start: January 12, 2017
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)