New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques

November 1, 2022 updated by: Matthew W. Urban, Mayo Clinic

New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques

The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has carotid plaque with > 50% stenosis
  • Subject is able to understand the study procedure and provide informed consent

Exclusion Criteria:

  • Subject is pregnant or breast feeding
  • Subject is unable to provide informed consent
  • Subject has contraindication to the use of the Lumason contrast agent.

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carotid Plaques with >70% Stenosis
Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
Combination product: Contrast-enhanced ultrasound
Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.
Other Names:
  • Lumason
Device: Shear Wave Elastography
Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.
Device: Ultrasound Examination
A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.
Active Comparator: Carotid Plaques with 50-69% Stenosis
Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
Combination product: Contrast-enhanced ultrasound
Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.
Other Names:
  • Lumason
Device: Shear Wave Elastography
Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.
Device: Ultrasound Examination
A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Completed All of the Ultrasound Examinations
Time Frame: 1 year after recruitment
Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).
1 year after recruitment

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew W Urban, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

November 15, 2017

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001863

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

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