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

NCT03335033 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 17-001863
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Plaque

Keywords

Carotid Plaque; Contrast Enhanced Ultrasound; Shear Wave Elastography; Endarterectomy; Stenosis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Completed All of the Ultrasound Examinations

  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).

  1 year after recruitment

Study Arms (2)

Carotid Plaques with >70% Stenosis

ACTIVE COMPARATOR

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.

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

Carotid Plaques with 50-69% Stenosis

ACTIVE COMPARATOR

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.

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

Interventions

Contrast-enhanced ultrasound COMBINATION_PRODUCT

Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.

Also known as: Lumason

Carotid Plaques with 50-69% Stenosis; Carotid Plaques with >70% Stenosis

Shear Wave Elastography DEVICE

Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.

Carotid Plaques with 50-69% Stenosis; Carotid Plaques with >70% Stenosis

Ultrasound Examination DEVICE

A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

Carotid Plaques with 50-69% Stenosis; Carotid Plaques with >70% Stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has carotid plaque with \> 50% stenosis
• Subject is able to understand the study procedure and provide informed consent

You may not qualify if:

• Subject is pregnant or breast feeding
• Subject is unable to provide informed consent
• Subject has contraindication to the use of the Lumason contrast agent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carotid Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew W. Urban
• Organization: Mayo Clinic

Urban.Matthew@mayo.edu

507-284-3703

Study Officials

• Matthew W Urban

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 7, 2017
• Study Start: November 15, 2017
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)