Phase 2
N=54
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
Carotid Artery Plaque
Bottom Line
View on ClinicalTrials.gov: NCT03335033 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Subjects Who Completed All of the Ultrasound Examinations — 17; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Contrast-enhanced ultrasound (Combination_product); Shear Wave Elastography (Device); Ultrasound Examination (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Completed All of the Ultrasound Examinations |
17; 37 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03335033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.