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

Phase 2

Completed

• Conditions: Carotid Artery Plaque
• Interventions: Combination Product: Contrast-enhanced ultrasound; Device: Shear Wave Elastography; Device: Ultrasound Examination

• 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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Study Start: 2017-11-15
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2022-11
• Results First Submitted: 2022-11-01
• Results First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Results First Posted: 2022-11-25
• Last Update Posted: 2022-11-25

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

Arm && Interventions

Group	Intervention	Description
Carotid Plaques with >70% Stenosis	Contrast-enhanced ultrasound	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.
Carotid Plaques with 50-69% Stenosis	Shear Wave Elastography	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.
Carotid Plaques with 50-69% Stenosis	Contrast-enhanced ultrasound	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.
Carotid Plaques with >70% Stenosis	Shear Wave Elastography	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.
Carotid Plaques with >70% Stenosis	Ultrasound Examination	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.
Carotid Plaques with 50-69% Stenosis	Ultrasound Examination	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Completed All of the Ultrasound Examinations	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).

Trial Locations

Locations (1)

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