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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Carotid Artery Plaque
- Sponsor
- Mayo Clinic
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Number of Subjects Who Completed All of the Ultrasound Examinations
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
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.
Investigators
Matthew W. Urban
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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).