Skip to main content
OpenTrials
Completed

NCT Number: NCT03335033

New Technologies to Determine Carotid Plaque Vulnerability 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carotid Artery Plaque Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Constriction, Pathologic Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast-enhanced ultrasound

Combination Product

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

Shear Wave Elastography

Device

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.

Ultrasound examination

Device

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2017
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.