ULTRA-VASC: Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04470687
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
40
1
1
12
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: contrast enhanced ultrafast ultrasound imaging
N/A

Detailed Description

see above

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Mar 17, 2022
Anticipated Study Completion Date :
Mar 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carotid plaque or stenosis ultrasound enhanced UF assesment

symptomatic or asymptomatic patients with atheromatous carotid stenosis scheduled for carotid endarterectomy

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital europeen Georges-Pompidou Paris France 75015

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Tristan MIRAULT, MD, PhD, Hopital europeen Georges-Pompidou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04470687
Other Study ID Numbers:
  • APHP180482
  • 2019-A03331-56
First Posted:
Jul 14, 2020
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021