Clinical trial NCT04470687: Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization
Official title: Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Prognosis
Contrast Media
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Neovascularization of the carotid plaque
timeFrame: end of inclusions
Secondary outcomes:
measure: Plaque stable or unstable
timeFrame: end of inclusions
measure: Plaque symptomatic or not
timeFrame: end of inclusions
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital europeen Georges-Pompidou
Study officials:
affiliation: Hopital europeen Georges-Pompidou
name: Tristan MIRAULT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: