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

Phase 2
Completed
Conditions
Carotid Artery Plaque
Registration Number
NCT03335033
Lead Sponsor
Mayo Clinic
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Number of Subjects Who Completed All of the Ultrasound Examinations1 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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States

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