Carotid StenosisACABIINCT02748941
Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control
A study testing HITS quantification, Ultrasound examinations, High Resolution MRI in people with Carotid Stenosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- HITS quantification, Ultrasound examinations, High Resolution MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2017to 12 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Service de radiologie
Bron, 69500
Philippe DOUEK, MD, 0472357233 ext. +33, philippe.douek@chu-lyon.fr
Adeline MANSUY, 4 72 11 52 25 ext. +33, adeline.mansuy@chu-lyon.fr
About this study
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.
Read more
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
- Being tested
- HITS quantification, Ultrasound examinations, High Resolution MRI
- Keywords
- unstable/stable atherosclerotic plaque, HITS, GSM, CEUS, HR MRI, mi-RNA
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITS quantification, Ultrasound examinations, High Resolution MRIDevice
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
| Study group | Role | What they receive |
|---|---|---|
| symptomatic and asymptomatic patients | Experimental | Not described Receives: Device: HITS quantification, Ultrasound examinations, High Resolution MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HITS per hour in doppler ultrasonography
Measured: Day 1
Ulceration > 2 mm presence in doppler ultrasonography
Measured: Day 1
GSM (Gray Scale Median) quantification in doppler ultrasonography
Measured: Day 1
CEUS (Contrast Enhanced UltraSound )
signal intensity amplification quantification and Ulceration > 2 mm
Measured: Day 1
hemorrhage intra-plaque présence in HR MRI
Measured: Day 1
large lipid-rich necrotic core présence in HR MRI
Measured: Day 1
ulceration or cap rupture présence in HR MRI
Measured: Day 1
Secondary outcomes (5)
hemorrhage intra-plaque
Compare the results of each modality for pathological analysis of the surgical equipment.
Measured: Day 1
large lipid-rich necrotic core
Compare the results of each modality for pathological analysis of the surgical equipment.
Measured: Day 1
ulceration or cap rupture
Compare the results of each modality for pathological analysis of the surgical equipment.
Measured: Day 1
shear stresses (Pa) on the surface of the plaque
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.
Measured: Day 1
mi-RNA identification
Identification of circulating mi-RNA specific to unstable atherosclerotic plaque by RT-PCR and comparison between case and control
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start12 Jan 2017
- Primary completion12 Feb 2027 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Bracco Imaging S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748941
- Sponsor's protocol ID
- 69HCL15_0458
- Acronym
- ACABII
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2016
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control
- ClinicalTrials.gov ID
- NCT02748941
- Acronym / sponsor ID
- ACABII / 69HCL15_0458
- Conditions
- Carotid Stenosis
- Keywords
- unstable/stable atherosclerotic plaque, HITS, GSM, CEUS, HR MRI, mi-RNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Fondation de France, Bracco Imaging S.p.A.
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic and asymptomatic patients | Experimental | Device: HITS quantification, Ultrasound examinations, High Resolution MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HITS quantification, Ultrasound examinations, High Resolution MRISimultaneously 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 | Device | symptomatic and asymptomatic patients |
Primary outcome
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
5 secondary outcomes
hemorrhage intra-plaque
Time frame: Day 1
large lipid-rich necrotic core
Time frame: Day 1
ulceration or cap rupture
Time frame: Day 1
shear stresses (Pa) on the surface of the plaque
Time frame: Day 1
mi-RNA identification
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HITS quantification, Ultrasound examinations, High Resolution MRI in people with Carotid Stenosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe DOUEK, MD ((0)472357233 ext. +33, philippe.douek@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HITS per hour in doppler ultrasonography (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.