Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization

Not Applicable

Completed

• Conditions: Carotid Artery Plaque; Carotid Artery Diseases; Carotid Atherosclerosis; Carotid Stenosis; Atheroma; Carotid Artery
• Interventions: Device: contrast enhanced ultrafast ultrasound imaging

• Registration Number: NCT04470687
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

see above

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Study Start: 2021-03-17
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotid plaque or stenosis ultrasound enhanced UF assesment	contrast enhanced ultrafast ultrasound imaging	symptomatic or asymptomatic patients with atheromatous carotid stenosis scheduled for carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
Neovascularization of the carotid plaque	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.

Secondary Outcome Measures

Name	Time	Method
Plaque symptomatic or not	end of inclusions	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
Plaque stable or unstable	end of inclusions	analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the plaque stability according to Oxford criteria

Trial Locations

Locations (1)

Hopital europeen Georges-Pompidou; 🇫🇷 Paris, France