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Trial record 16 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

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
Sponsor:
Collaborators:
Fondation de France
Bracco Imaging S.p.A.
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Carotid Stenosis Device: HITS quantification, Ultrasound examinations, High Resolution MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020

Arm Intervention/treatment
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:

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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748941


Contacts
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Contact: Stéphane LUONG, MD (0)4 27 85 77 66 ext +33 stéphane.luong@chu-lyon.fr
Contact: Adeline MANSUY, CRA (0)4 72 11 5225 ext +33 adeline.mansuy@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Service de radiologie Recruiting
Bron, France, 69500
Contact: Stéphane Luong, MD    4 27 85 77 66 ext +33    stephane.luong@chu-lyon.fr   
Contact: Adeline MANSUY    4 72 11 52 25 ext +33    adeline.mansuy@chu-lyon.fr   
Principal Investigator: Stéphane Luong, MD         
Sub-Investigator: Laura MECHTOUFF, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Fondation de France
Bracco Imaging S.p.A.

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02748941     History of Changes
Other Study ID Numbers: 69HCL15_0458
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
unstable/stable atherosclerotic plaque
HITS
GSM
CEUS
HR MRI
mi-RNA

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases