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Trial record 36 of 46 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

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

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ClinicalTrials.gov Identifier: NCT03335033
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew W. Urban, 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.

Condition or disease Intervention/treatment Phase
Carotid Artery Plaque Combination Product: Contrast-enhanced ultrasound Device: Shear Wave Elastography Device: Ultrasound Examination Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Carotid Plaques with >70% Stenosis
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
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.
Other Name: Lumason

Device: Shear Wave Elastography
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.

Device: Ultrasound Examination
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.

Active Comparator: Carotid Plaques with 50-69% Stenosis
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
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.
Other Name: Lumason

Device: Shear Wave Elastography
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.

Device: Ultrasound Examination
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.




Primary Outcome Measures :
  1. Number of Subjects who Completed All of the Ultrasound Examinations [ Time Frame: 1 year after recruitment ]
    Completion of ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335033


Contacts
Contact: Matthew W Urban, Ph.D. 507-538-1522 Urban.Matthew@mayo.edu
Contact: Jennifer Murphy 507-284-9318 Murphy.Jennifer@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Matthew W Urban, Ph.D.    507-538-1522    Urban.Matthew@mayo.edu   
Principal Investigator: Matthew W Urban, Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew W Urban Mayo Clinic

Responsible Party: Matthew W. Urban, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03335033     History of Changes
Other Study ID Numbers: 17-001863
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Matthew W. Urban, Mayo Clinic:
Carotid Plaque
Contrast Enhanced Ultrasound
Shear Wave Elastography
Endarterectomy
Stenosis

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases