Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization

Carotid Stenosis Clinical Trial

— ULTRA-VASC  

Official title:

Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470687
• Other study ID #: APHP180482
• Secondary ID: 2019-A03331-56
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Tristan MIRAULT, MD, PhD
• Phone: +33 (0)1.56.09.26.51
• Email: tristan.mirault[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

see above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient is over 18

• The patient is scheduled for carotid endarterectomy within 30 days at most

• The patient has a social security system

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atheroma; Carotid Artery
• Atherosclerosis
• Carotid Artery Diseases
• Carotid Artery Plaque
• Carotid Atherosclerosis
• Carotid Stenosis
• Neovascularization, Pathologic
• Plaque, Atherosclerotic

Intervention

Device:
• contrast enhanced ultrafast ultrasound imaging
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

Locations

Country	Name	City	State
France	Hopital europeen Georges-Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	end of inclusions
Secondary	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	end of inclusions
Secondary	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	end of inclusions