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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Carotid Artery Plaque

Treatments: Device: Shear Wave Elastography; Device: Ultrasound Examination; Combination Product: Contrast-enhanced ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03335033

17-001863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Carotid Plaques with >70% Stenosis

Active Comparator group

Description:

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.

Treatment:

Device: Ultrasound Examination

Device: Shear Wave Elastography

Combination Product: Contrast-enhanced ultrasound

Carotid Plaques with 50-69% Stenosis

Active Comparator group

Description:

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.

Treatment:

Device: Ultrasound Examination

Device: Shear Wave Elastography

Combination Product: Contrast-enhanced ultrasound