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NCT Number: NCT02748941

Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Service de radiologie

Bron, 69500, France

Location status: Recruiting

Location contact

Adeline MANSUY

CONTACT

[email protected]

4 72 11 52 25 ext. +33

Laura MECHTOUFF, MD

SUB_INVESTIGATOR

Philippe DOUEK, MD

CONTACT

[email protected]

0472357233 ext. +33

Stéphane Luong, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of HITS per hour in doppler ultrasonography

    Time frame: Day 1

  2. Ulceration > 2 mm presence in doppler ultrasonography

    Time frame: Day 1

  3. GSM (Gray Scale Median) quantification in doppler ultrasonography

    Time frame: Day 1

  4. CEUS (Contrast Enhanced UltraSound )

    Time frame: Day 1

    signal intensity amplification quantification and Ulceration > 2 mm

  5. hemorrhage intra-plaque présence in HR MRI

    Time frame: Day 1

  6. large lipid-rich necrotic core présence in HR MRI

    Time frame: Day 1

  7. ulceration or cap rupture présence in HR MRI

    Time frame: Day 1

Secondary outcomes

  1. hemorrhage intra-plaque

    Time frame: Day 1

    Compare the results of each modality for pathological analysis of the surgical equipment.

  2. large lipid-rich necrotic core

    Time frame: Day 1

    Compare the results of each modality for pathological analysis of the surgical equipment.

  3. ulceration or cap rupture

    Time frame: Day 1

    Compare the results of each modality for pathological analysis of the surgical equipment.

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline MANSUY, CRA

CONTACT

[email protected]

(0)4 72 11 5225 ext. +33

Philippe DOUEK, MD

CONTACT

[email protected]

(0)472357233 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Bracco Imaging S.p.A.
  • Fondation de France

Registry information

Acronym: ACABII

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2016
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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