Carotid StenosisULTRA-VASCNCT04470687
Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization
A study testing contrast enhanced ultrafast ultrasound imaging in people with Carotid Stenosis and Carotid Artery Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis
- What is being tested?
- contrast enhanced ultrafast ultrasound imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The patient is over 18
- The patient is scheduled for carotid endarterectomy within 30 days at most
- The patient has a social security system
Who cannot join
- Non-atheromatous carotid stenosis (radiation)
- Contraindication of the use of SonoVue ultrasound contrast media. Hypersensitivity to the active ingredient or any of the following excipients: Macrogol 4000; Distearoylphosphatidylcholine; Dipalmitoylphosphatidylglycerol sodium; Palmitic acid.
- The patient has any of the following conditions: right-left shunt, severe pulmonary hypertension (pulmonary blood pressure > 90 mm Hg), uncontrolled systemic hypertension and respiratory distress syndrome.
- Lack of social security coverage, patient under justice
- Allergy to ultrasound gel
- Pregnancy. (As a precautionary measure, it is best to avoid using SonoVue during pregnancy according to SPC)
- Patient under guardianship or curatorship or under the protection of justice.
- Patient unable or unwilling to give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization
Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. Patients with stenosis over 70% are therefore offered an endarterectomy, an operation to remove carotid plaque, to prevent future strokes[1]. In asymptomatic patients, the degree of stenosis is a limited predictor, and better risk stratification is required to assess the degree of plaque vulnerability and stroke risk of the patient. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable and dependent benefit/risk balance for each patient. A number of imaging parameters have been studied: ulceration, heterogeneity, vascularization of the plaque for example, but their place is not well defined [2].
The usual evaluation of carotid stenosis is by conventional Doppler ultrasound with calculation of the degree of stenosis according to the NASCET criteria.
Read more
For symptomatic stenoses the intervention is recommended when above 70% and is discussed from 50% to 70% of NASCET stenosis degree.
For asymptomatic stenoses, the procedure is discussed when above 60% taking into account the patient's life expectancy, the risk of the surgery and the unstable nature of the plaque [2].
Destabilization of the carotid plaque is partially induced by inflammation associated with neo-vascularization. The detection of these new vessels by conventional contrast ultrasound has already shown a distinction between stable and unstable plaques, by the presence or absence of microbubbles in the plaque. However, this assessment is not very precise and only the most vascularized plaques can be detected. Ultrafast ultrasound Imaging is a new ultrasonic Imaging modality that allows detecting low speed flows, a tiny vascular structure within the vessel wall.
RESEARCH HYPOTHESIS Plaques neo-vascularization would be more precisely detected and characterized by ultrafast imaging coupled with microbubble injection than conventional ultrasound imaging.
A better assessment of plaque instability could improve the selection of patients for carotid endarterectomy and increase the benefit/risk ratio of this preventive surgery.
Read the detailed description
see above
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Plaque, Atheroma; Carotid Artery
- Being tested
- contrast enhanced ultrafast ultrasound imaging
- Keywords
- Carotid Stenosis, Endarterectomy, Carotid, Carotid Arteries, Carotid Artery, Internal, Stroke, Ultrasonography, Ultrasonography, Doppler, diagnostic imaging, Prognosis, Contrast Media
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced ultrafast ultrasound imagingDevice
Ultrasound contrast medium: SonoVue 8µL/mL (Bracco International BV) Ultrasound scanner: Aixplorer® device marketed by SuperSonic Imagine©, CE Doppler UltraFast™Doppler, contrast ultrasound (CEUS), color Doppler and ultra-sensitive energy Doppler, high-performance directional energy Doppler, Elastography ShearWave™ UF-Doppler (UltraFast-Doppler) and microbubble injection (SonoVue) Apparatus for performing the UF Doppler sequence: Aixplorer, manufacturer : Supersonic Imagine, Aix-en-Provence, France, CE Marking.
3D RCA dedicated vascular probe with dedicated Doppler sequences
| Study group | Role | What they receive |
|---|---|---|
| Carotid plaque or stenosis ultrasound enhanced UF assesment | Experimental | symptomatic or asymptomatic patients with atheromatous carotid stenosis scheduled for carotid endarterectomy Receives: Device: contrast enhanced ultrafast ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neovascularization of the carotid plaque
Correlation BETWEEN the average signal strength of the carotid plaque analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the number of neovessels determined by histological analysis of the carotid plaque (number of neovessels per section) studied.
Measured: end of inclusions
Secondary outcomes (2)
Plaque stable or unstable
analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the plaque stability according to Oxford criteria
Measured: end of inclusions
Plaque symptomatic or not
Comparison BETWEEN the average signal strength of the carotid plaque analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the symptomatic or asymptomatic status for stroke of the patient
Measured: end of inclusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start17 Mar 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
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 Assistance Publique - Hôpitaux de ParisThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan MIRAULT, MD, PhD, Principal investigator, Hopital europeen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470687
- Sponsor's protocol ID
- APHP180482
- Other IDs
- 2019-A03331-56
- Acronym
- ULTRA-VASC
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization
- ClinicalTrials.gov ID
- NCT04470687
- Acronym / sponsor ID
- ULTRA-VASC / APHP180482
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Plaque, Atheroma; Carotid Artery
- Keywords
- Carotid Stenosis, Endarterectomy, Carotid, Carotid Arteries, Carotid Artery, Internal, Stroke, Ultrasonography, Ultrasonography, Doppler, diagnostic imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. Patients with stenosis over 70% are therefore offered an endarterectomy, an operation to remove carotid plaque, to prevent future strokes[1]. In asymptomatic patients, the degree of stenosis is a limited predictor, and better risk stratification is required to assess the degree of plaque vulnerability and stroke risk of the patient. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable and dependent benefit/risk balance for each patient. A number of imaging parameters have been studied: ulceration, heterogeneity, vascularization of the plaque for example, but their place is not well defined [2].
The usual evaluation of carotid stenosis is by conventional Doppler ultrasound with calculation of the degree of stenosis according to the NASCET criteria.
For symptomatic stenoses the intervention is recommended when above 70% and is discussed from 50% to 70% of NASCET stenosis degree.
For asymptomatic stenoses, the procedure is discussed when above 60% taking into account the patient's life expectancy, the risk of the surgery and the unstable nature of the plaque [2].
Destabilization of the carotid plaque is partially induced by inflammation associated with neo-vascularization. The detection of these new vessels by conventional contrast ultrasound has already shown a distinction between stable and unstable plaques, by the presence or absence of microbubbles in the plaque. However, this assessment is not very precise and only the most vascularized plaques can be detected. Ultrafast ultrasound Imaging is a new ultrasonic Imaging modality that allows detecting low speed flows, a tiny vascular structure within the vessel wall.
RESEARCH HYPOTHESIS Plaques neo-vascularization would be more precisely detected and characterized by ultrafast imaging coupled with microbubble injection than conventional ultrasound imaging.
A better assessment of plaque instability could improve the selection of patients for carotid endarterectomy and increase the benefit/risk ratio of this preventive surgery.
Detailed description
see above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid plaque or stenosis ultrasound enhanced UF assesment | Experimental | Device: contrast enhanced ultrafast ultrasound imagingsymptomatic or asymptomatic patients with atheromatous carotid stenosis scheduled for carotid endarterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is over 18
- The patient is scheduled for carotid endarterectomy within 30 days at most
- The patient has a social security system
Key exclusion criteria (8 listed)
- Non-atheromatous carotid stenosis (radiation)
- Contraindication of the use of SonoVue ultrasound contrast media. Hypersensitivity to the active ingredient or any of the following excipients: Macrogol 4000; Distearoylphosphatidylcholine; Dipalmitoylphosphatidylglycerol sodium; Palmitic acid.
- The patient has any of the following conditions: right-left shunt, severe pulmonary hypertension (pulmonary blood pressure > 90 mm Hg), uncontrolled systemic hypertension and respiratory distress syndrome.
- Lack of social security coverage, patient under justice
- Allergy to ultrasound gel
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 |
|---|---|---|
| contrast enhanced ultrafast ultrasound imagingUltrasound contrast medium: SonoVue 8µL/mL (Bracco International BV) Ultrasound scanner: Aixplorer® device marketed by SuperSonic Imagine©, CE Doppler UltraFast™Doppler, contrast ultrasound (CEUS), color Doppler and ultra-sensitive energy Doppler, high-performance directional energy Doppler, Elastography ShearWave™ UF-Doppler (UltraFast-Doppler) and microbubble injection (SonoVue) Apparatus for performing the UF Doppler sequence: Aixplorer, manufacturer : Supersonic Imagine, Aix-en-Provence, France, CE Marking. 3D RCA dedicated vascular probe with dedicated Doppler sequences | Device | Carotid plaque or stenosis ultrasound enhanced UF assesment |
Primary outcome
Neovascularization of the carotid plaque
Time frame: end of inclusions
Correlation BETWEEN the average signal strength of the carotid plaque analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the number of neovessels determined by histological analysis of the carotid plaque (number of neovessels per section) studied.
2 secondary outcomes
Plaque stable or unstable
Time frame: end of inclusions
Plaque symptomatic or not
Time frame: end of inclusions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared
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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. This study is not recruiting at the moment.
Tristan MIRAULT, MD, PhD principal investigator
Hopital europeen Georges-Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast enhanced ultrafast ultrasound imaging in people with Carotid Stenosis and Carotid Artery Diseases, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neovascularization of the carotid plaque (time frame: end of inclusions). 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 11 Jul 2024.