3D Contrast Enhanced Microvascular Ultrasound of Carotid Atherosclerosis for the Detection of Carotid Plaque Neo-Revascularisation. (Carotid Neo3D)

April 9, 2026 updated by: London North West Healthcare NHS Trust

Atherosclerotic plaques, the build-up of fatty materials within our arteries, can develop over a long period of time without causing any symptoms.

These plaques may continue to grow and rupture causing narrowing and blockages of the blood vessels. This can lead to serious cardiovascular disease such as a heart attack or stroke causing over 160,000 deaths each year.

Lots of research has been done on why particular groups of people may develop atherosclerosis and controlling risk factors such as diabetes and high blood pressure go a long way to reduce people's risks. However, despite the treatments we have available and controlling these risk factors, some people unfortunately still go on to develop a potentially serious disease.

Further research has shown us that certain plaques in the blood vessels may be more vulnerable to rupturing compared to others. So far we know that plaques with thin caps, soft centres or those that are able to grow their own tiny blood vessels are more likely to rupture. We have now started to develop new imaging methods to try and help us detect these vulnerabilities. The hope is by being able to detect more vulnerable plaques we may be able to treat these earlier and therefore more effectively.

There are different scans available to try and visualise the tiny vessels within these plaques in the neck arteries. These include, MRI (a Magnetic Resonance Imaging scan, taking pictures using a small tunnel), CT (Computed Tomography, uses a ring-shaped machine to take pictures), and ultrasound. Ultrasound has the benefit of being free of ionising radiation and iodinated contrast, therefore posing less risk to patients. However, current ultrasound uses 2D ultrasound. Although this has shown promising results, our blood vessels and any plaques are 3D structures so we don't get to see the whole plaque using 2D imaging and therefore may miss important information. The available 3D probes in use at the moment are not able to visualise the tiny vessels accurately enough.

This study uses a different 3D ultrasound probe and ultrasound machine that is able to produce many more images than our usual probes. By taking images with this probe and using offline computer programmes to track the contrast through structures we hope that this system will be able to give us a visualisation of the whole plaque enabling us to detect any new blood vessels more accurately.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age>18 years old.
  2. Previously consent for participation in the SECURE trial and have undergone carotid CEUS.
  3. Found to have at least one carotid plaque present on carotid CEUS.
  4. Able to give informed consent to participate in the study and its procedures.

Exclusion Criteria:

  1. Age <18 years old.
  2. Unable to provide informed consent to participate in the study and its procedures.
  3. Allergy to microbubble contrast agents.
  4. Known pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D contrast enhanced microvascular carotid ultrasound
Patients will be cannulated in order to allow infusion of SonoVue® (Bracco, Milan) microbubble contrast agent. A 5ml vial will be made up into an infusion and given at a rate to allow adequate arterial opacification according to standard clinical practices. Initial 2D B-mode ultrasound images will be taken of the carotid arteries using a standard 3- to 11- MHz linear transducer on an EPIC CVx machine (Philips Medical Systems). This will confirm the presence of plaque and allow a scouted location for the desired row-column array transducer images. CEUS images will be taken with the 2D matrix array probe to allow comparative baseline images. Once the desired area has been located and CEUS images have confirmed plaque, the row-column array probe, manipulated by a clinician, will be used to take the 3D images. Microbubble contrast infusion will be given followed by a scan with the row-column array transducer which should take 2-5 minutes, taking multiple acquisitions if required. A member
Diagnostic test: 3D Contrast Enhanced Microvascular Carotid Ultrasound
Patients will be cannulated in order to allow infusion of SonoVue® (Bracco, Milan) microbubble contrast agent. A 5ml vial will be made up into an infusion and given at a rate to allow adequate arterial opacification according to standard clinical practices. Initial 2D B-mode ultrasound images will be taken of the carotid arteries using a standard 3- to 11- MHz linear transducer on an EPIC CVx machine (Philips Medical Systems). This will confirm the presence of plaque and allow a scouted location for the desired row-column array transducer images. CEUS images will be taken with the 2D matrix array probe to allow comparative baseline images. Once the desired area has been located and CEUS images have confirmed plaque, the row-column array probe, manipulated by a clinician, will be used to take the 3D images. Microbubble contrast infusion will be given followed by a scan with the row-column array transducer which should take 2-5 minutes, taking multiple acquisitions if required. A member

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of carotid plaque neovascularisation
Time Frame: Baseline
Can the 3D row-column array transducer detect intra-plaque neovascularisation in carotid plaques comparable to 2D CEUS
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Roxy Senior, MD, LNWH Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC/2024/001
  • 349094 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carotid Atherosclerosis

Clinical Trials on 3D Contrast Enhanced Microvascular Carotid Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe