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Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk

Primary Purpose

Plaque, Atherosclerotic, Carotid Artery Plaque, Carotid Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic Radiation Force Impulse (ARFI) ultrasound
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Plaque, Atherosclerotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. aged 18 years or older
  2. having 50-99% stenotic symptomatic carotid plaque with clinical indication for endarterectomy
  3. having 50-69% stenotic asymptomatic carotid plaque without clinical indication for endarterectomy

Exclusion Criteria:

  1. prior CEA or carotid stenting
  2. carotid occlusion
  3. vasculitis
  4. malignancy
  5. inability to provide informed consent
  6. prior radiation therapy to the neck
  7. treatment with immunomodulating drugs
  8. oncological disease.

Sites / Locations

  • The University of North Carolina at Chapel Hill HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Symptomatic with 50-69% stenosis

Symptomatic with 70-99% stenosis

Asymptomatic with 70-99% stenosis

Asymptomatic with 50-69% stenosis

Arm Description

Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 50-69% stenotic carotid plaque with associated neurological symptoms. Acoustic Radiation Force Impulse (ARFI) ultrasound imaging will be performed on the carotid plaque.

Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 70-99% stenotic carotid plaque with associated neurological symptoms. ARFI ultrasound imaging will be performed on the carotid plaque.

Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 70-99% stenotic carotid plaque without associated neurological symptoms. ARFI ultrasound imaging will be performed on the carotid plaque.

Patients 18 years of age or older who have been diagnosed with 50-69% carotid artery stenosis without clinical indication for CEA.

Outcomes

Primary Outcome Measures

Acoustic Radiation Force Impulse (ARFI) imaging
Ability of ARFI imaging to detect carotid plaque features and measure their size

Secondary Outcome Measures

VoA AUC for thin or ruptured fibrous caps (TRFC) at 8 MHz fundamental
Area Under the Curve (AUC) for the ability of ARFI Variance of Acceleration (VoA) obtained at 8 MHz fundamental frequency to detect thin or ruptured fibrous cap
PD AUC for TRFC at 8 MHz fundamental
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect thin or ruptured fibrous cap
VoA AUC for TRFC at 12 MHz fundamental
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect thin or ruptured fibrous cap
PD AUC for TRFC at 12 MHz fundamental
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect thin or ruptured fibrous cap
VoA AUC for TRFC at 12 MHz harmonic
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect thin or ruptured fibrous cap
PD AUC for TRFC at 12 MHz harmonic
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect thin or ruptured fibrous cap
VoA AUC for LRNC at 8 MHz fundamental
AUC for the ability of ARFI VoA obtained at 8 MHz fundamental frequency to detect lipid rich necrotic core (LRNC)
PD AUC for LRNC at 8 MHz fundamental
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect lipid rich necrotic core
VoA AUC for LRNC at 12 MHz fundamental
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect lipid rich necrotic core
PD AUC for LRNC at 12 MHz fundamental
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect lipid rich necrotic core
VoA AUC for LRNC at 12 MHz harmonic
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect lipid rich necrotic core
PD AUC for LRNC at 12 MHz harmonic
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect lipid rich necrotic core
VoA AUC for IPH at 8 MHz fundamental
AUC for the ability of ARFI VoA obtained at 8 MHz fundamental frequency to detect intraplaque hemorrhage
PD AUC for IPH at 8 MHz fundamental
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect intraplaque hemorrhage
VoA AUC for IPH at 12 MHz fundamental
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect intraplaque hemorrhage
PD AUC for IPH at 12 MHz fundamental
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect intraplaque hemorrhage
VoA AUC for IPH at 12 MHz harmonic
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect intraplaque hemorrhage
PD AUC for IPH at 12 MHz harmonic
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect intraplaque hemorrhage
VoA bias for TRFC thickness at 8 MHz fundamental
Bland Altman-derived bias in VoA-based TRFC thickness measurement 8 MHz fundamental frequency
PD bias for TRFC thickness at 8 MHz fundamental
Bland Altman-derived bias in PD-based TRFC thickness measurement 8 MHz fundamental frequency
VoA bias for TRFC thickness at 12 MHz fundamental
Bland Altman-derived bias in VoA-based TRFC thickness measurement at 12 MHz fundamental frequency
PD bias for TRFC thickness at 12 MHz fundamental
Bland Altman-derived bias in PD-based TRFC thickness measurement at 12 MHz fundamental frequency
VoA bias for TRFC thickness at 12 MHz harmonic
Bland Altman-derived bias in VoA-based TRFC thickness measurement at 12 MHz harmonic frequency
PD bias for TRFC thickness at 12 MHz harmonic
Bland Altman-derived bias in PD-based TRFC thickness measurement at 12 MHz harmonic frequency
VoA bias for LRNC size at 8 MHz fundamental
Bland Altman-derived bias in VoA-based LRNC size measurement at 8 MHz fundamental frequency
PD bias for LRNC size at 8 MHz fundamental
Bland Altman-derived bias in PD-based LRNC size measurement at 8 MHz fundamental frequency
VoA bias for LRNC size at 12 MHz fundamental
Bland Altman-derived bias in VoA-based LRNC size measurement at 12 MHz fundamental frequency
PD bias for LRNC size at 12 MHz fundamental
Bland Altman-derived bias in PD-based LRNC size measurement at 12 MHz fundamental frequency
VoA bias for LRNC size at 12 MHz harmonic
Bland Altman-derived bias in VoA-based LRNC size measurement at 12 MHz harmonic frequency
PD bias for LRNC size at 12 MHz harmonic
Bland Altman-derived bias in PD-based LRNC size measurement at 12 MHz harmonic frequency
VoA bias for IPH size at 8 MHz fundamental
Bland Altman-derived bias in VoA-based IPH size measurement at 8 MHz fundamental frequency
PD bias for IPH size at 8 MHz fundamental
Bland Altman-derived bias in PD-based IPH size measurement at 8 MHz fundamental frequency
VoA bias for IPH size at 12 MHz fundamental
Bland Altman-derived bias in VoA-based IPH size measurement at 12 MHz fundamental frequency
PD bias for IPH size at 12 MHz fundamental
Bland Altman-derived bias in PD-based IPH size measurement at 12 MHz fundamental frequency
VoA bias for IPH size at 12 MHz harmonic
Bland Altman-derived bias in VoA-based IPH size measurement at 12 MHz harmonic frequency
PD bias for IPH size at 12 MHz harmonic
Bland Altman-derived bias in PD-based IPH size measurement at 12 MHz harmonic frequency
VoA prevalence of TRFC detection at 8 MHz fundamental
prevalence of reader-detected TRFC from VoA at 8 MHz fundamental frequency
PD prevalence of TRFC detection at 8 MHz fundamental
prevalence of reader-detected TRFC from PD at 8 MHz fundamental frequency
VoA prevalence of TRFC detection at 12 MHz fundamental
prevalence of reader-detected TRFC from VoA at 12 MHz fundamental frequency
PD prevalence of TRFC detection at 12 MHz fundamental
prevalence of reader-detected TRFC from PD at 12 MHz fundamental frequency
VoA prevalence of TRFC detection at 12 MHz harmonic
prevalence of reader-detected TRFC from VoA at 12 MHz harmonic frequency
PD prevalence of TRFC detection at 12 MHz harmonic
prevalence of reader-detected TRFC from PD at 12 MHz harmonic frequency
VoA prevalence of LRNC detection at 8 MHz fundamental
prevalence of reader-detected LRNC from VoA at 8 MHz fundamental frequency
PD prevalence of LRNC detection at 8 MHz fundamental
prevalence of reader-detected LRNC from PD at 8 MHz fundamental frequency
VoA prevalence of LRNC detection at 12 MHz fundamental
prevalence of reader-detected LRNC from VoA at 12 MHz fundamental frequency
PD prevalence of LRNC detection at 12 MHz fundamental
prevalence of reader-detected LRNC from PD at 12 MHz fundamental frequency
VoA prevalence of LRNC detection at 12 MHz harmonic
prevalence of reader-detected LRNC from VoA at 12 MHz harmonic frequency
PD prevalence of LRNC detection at 12 MHz harmonic
prevalence of reader-detected LRNC from PD at 12 MHz harmonic frequency
VoA prevalence of IPH detection at 8 MHz fundamental
prevalence of reader-detected IPH from VoA at 8 MHz fundamental frequency
PD prevalence of IPH detection at 8 MHz fundamental
prevalence of reader-detected IPH from PD at 8 MHz fundamental frequency
VoA prevalence of IPH detection at 12 MHz fundamental
prevalence of reader-detected IPH from VoA at 12 MHz fundamental frequency
PD prevalence of IPH detection at 12 MHz fundamental
prevalence of reader-detected IPH from PD at 12 MHz fundamental frequency
VoA prevalence of IPH detection at 12 MHz harmonic
prevalence of reader-detected IPH from VoA at 12 MHz harmonic frequency
PD prevalence of IPH detection at 12 MHz harmonic
prevalence of reader-detected IPH from PD at 12 MHz harmonic frequency

Full Information

First Posted
August 16, 2019
Last Updated
May 9, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04063709
Brief Title
Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk
Official Title
Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
July 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is a leading cause of death and disability in the United States and around the world. The goal of this work is to develop and test a noninvasive ultrasound-based imaging technology to better identify patients at high risk of stroke so that appropriate and timely intervention may be administered to prevent it.
Detailed Description
Although stroke remains a leading cause of death in the United States, incidence and mortality rates have declined over the past two decades in association with advanced pharmaceutical therapies and revascularization, primarily by carotid endarterectomy (CEA). While CEA's efficacy for preventing stroke in patients with severe (≥70%) carotid artery stenosis and neurological symptoms is well documented, the surgical intervention's usefulness decreases as stroke risk falls in patients with less severe stenosis and patients without symptoms. It is estimated that as many as 13 out of 14 symptomatic patients with 50-69% stenosis and 21 out of 22 asymptomatic patients with 70-99% stenosis undergo CEA surgery unnecessarily. These data demonstrate the inadequacy of degree of stenosis as the primary indication of stroke risk and underscore the urgent yet unmet need for improved biomarkers that differentiate patients at low risk of embolic stroke from those in need of CEA to prevent it. This urgent need for improving CEA indication could be met by assessing the structure and composition of carotid plaques. Plaques composed of thin or ruptured fibrous caps (TRFC), large lipid rich necrotic cores (LRNC), and intraplaque hemorrhage (IPH) are associated with thrombosis in morphological studies from autopsy. Further, plaque hemorrhage and increased intraplaque vessel formation in CEA specimens are independently related to future cardio- and cerebrovascular events or interventions. Finally, previous stroke or transient ischemic attack (TIA) is associated with TRFC and IPH - while increased risk of future stroke or TIA is conferred by TRFC, LRNC, and IPH - in human carotid plaques as determined by in vivo magnetic resonance imaging (MRI). The goal of this work is to develop a low-cost, noninvasive imaging method that reliably delineates carotid plaque structure and composition and is suitable for widespread diagnostic application. Previous research has demonstrated that Acoustic Radiation Force Impulse (ARFI) ultrasound delineates LRNC/IPH, collagen/calcium deposits, and TRFC in human carotid plaque, in vivo, with TRFC thickness measurement as low as 0.49 mm - the mean thickness associated with rupture. This project will exploit ARFI Variance of Acceleration (VoA) imaging, higher center frequencies, and harmonic imaging to newly enable separate discrimination of TRFC, LRNC, and IPH and accurate feature size measurement. The investigators will determine the association between advanced ARFI's plaque characterization and recent history of ipsilateral stroke or TIA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Atherosclerotic, Carotid Artery Plaque, Carotid Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This unblinded, open-label, exploratory study will be conducted in 60 patients with clinical indication for carotid endarterectomy (CEA). Among these 60 patients, N=20 will be symptomatic with 50-69% carotid artery stenosis, N=20 will be symptomatic with 70-99% stenosis, and N=20 will be asymptomatic with 70-99% stenosis. The study will also be conducted in N=20 additional patients without clinical indication for CEA. These patients will be asymptomatic with 50-60% stenosis.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic with 50-69% stenosis
Arm Type
Experimental
Arm Description
Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 50-69% stenotic carotid plaque with associated neurological symptoms. Acoustic Radiation Force Impulse (ARFI) ultrasound imaging will be performed on the carotid plaque.
Arm Title
Symptomatic with 70-99% stenosis
Arm Type
Experimental
Arm Description
Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 70-99% stenotic carotid plaque with associated neurological symptoms. ARFI ultrasound imaging will be performed on the carotid plaque.
Arm Title
Asymptomatic with 70-99% stenosis
Arm Type
Experimental
Arm Description
Patients 18 years of age or older who have been selected by their treating physician to be in need of carotid revascularization by CEA, with 70-99% stenotic carotid plaque without associated neurological symptoms. ARFI ultrasound imaging will be performed on the carotid plaque.
Arm Title
Asymptomatic with 50-69% stenosis
Arm Type
Experimental
Arm Description
Patients 18 years of age or older who have been diagnosed with 50-69% carotid artery stenosis without clinical indication for CEA.
Intervention Type
Diagnostic Test
Intervention Name(s)
Acoustic Radiation Force Impulse (ARFI) ultrasound
Intervention Description
ARFI imaging is an ultrasound-based, noninvasive imaging method and will be used in accordance with approved labeling.
Primary Outcome Measure Information:
Title
Acoustic Radiation Force Impulse (ARFI) imaging
Description
Ability of ARFI imaging to detect carotid plaque features and measure their size
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
VoA AUC for thin or ruptured fibrous caps (TRFC) at 8 MHz fundamental
Description
Area Under the Curve (AUC) for the ability of ARFI Variance of Acceleration (VoA) obtained at 8 MHz fundamental frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
PD AUC for TRFC at 8 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
VoA AUC for TRFC at 12 MHz fundamental
Description
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
PD AUC for TRFC at 12 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
VoA AUC for TRFC at 12 MHz harmonic
Description
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
PD AUC for TRFC at 12 MHz harmonic
Description
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect thin or ruptured fibrous cap
Time Frame
During the procedure
Title
VoA AUC for LRNC at 8 MHz fundamental
Description
AUC for the ability of ARFI VoA obtained at 8 MHz fundamental frequency to detect lipid rich necrotic core (LRNC)
Time Frame
During the procedure
Title
PD AUC for LRNC at 8 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect lipid rich necrotic core
Time Frame
During the procedure
Title
VoA AUC for LRNC at 12 MHz fundamental
Description
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect lipid rich necrotic core
Time Frame
During the procedure
Title
PD AUC for LRNC at 12 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect lipid rich necrotic core
Time Frame
During the procedure
Title
VoA AUC for LRNC at 12 MHz harmonic
Description
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect lipid rich necrotic core
Time Frame
During the procedure
Title
PD AUC for LRNC at 12 MHz harmonic
Description
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect lipid rich necrotic core
Time Frame
During the procedure
Title
VoA AUC for IPH at 8 MHz fundamental
Description
AUC for the ability of ARFI VoA obtained at 8 MHz fundamental frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
PD AUC for IPH at 8 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 8 MHz fundamental frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
VoA AUC for IPH at 12 MHz fundamental
Description
AUC for the ability of ARFI VoA obtained at 12 MHz fundamental frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
PD AUC for IPH at 12 MHz fundamental
Description
AUC for the ability of ARFI PD obtained at 12 MHz fundamental frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
VoA AUC for IPH at 12 MHz harmonic
Description
AUC for the ability of ARFI VoA obtained at 12 MHz harmonic frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
PD AUC for IPH at 12 MHz harmonic
Description
AUC for the ability of ARFI PD obtained at 12 MHz harmonic frequency to detect intraplaque hemorrhage
Time Frame
During the procedure
Title
VoA bias for TRFC thickness at 8 MHz fundamental
Description
Bland Altman-derived bias in VoA-based TRFC thickness measurement 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for TRFC thickness at 8 MHz fundamental
Description
Bland Altman-derived bias in PD-based TRFC thickness measurement 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for TRFC thickness at 12 MHz fundamental
Description
Bland Altman-derived bias in VoA-based TRFC thickness measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for TRFC thickness at 12 MHz fundamental
Description
Bland Altman-derived bias in PD-based TRFC thickness measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for TRFC thickness at 12 MHz harmonic
Description
Bland Altman-derived bias in VoA-based TRFC thickness measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD bias for TRFC thickness at 12 MHz harmonic
Description
Bland Altman-derived bias in PD-based TRFC thickness measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
VoA bias for LRNC size at 8 MHz fundamental
Description
Bland Altman-derived bias in VoA-based LRNC size measurement at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for LRNC size at 8 MHz fundamental
Description
Bland Altman-derived bias in PD-based LRNC size measurement at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for LRNC size at 12 MHz fundamental
Description
Bland Altman-derived bias in VoA-based LRNC size measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for LRNC size at 12 MHz fundamental
Description
Bland Altman-derived bias in PD-based LRNC size measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for LRNC size at 12 MHz harmonic
Description
Bland Altman-derived bias in VoA-based LRNC size measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD bias for LRNC size at 12 MHz harmonic
Description
Bland Altman-derived bias in PD-based LRNC size measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
VoA bias for IPH size at 8 MHz fundamental
Description
Bland Altman-derived bias in VoA-based IPH size measurement at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for IPH size at 8 MHz fundamental
Description
Bland Altman-derived bias in PD-based IPH size measurement at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for IPH size at 12 MHz fundamental
Description
Bland Altman-derived bias in VoA-based IPH size measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD bias for IPH size at 12 MHz fundamental
Description
Bland Altman-derived bias in PD-based IPH size measurement at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA bias for IPH size at 12 MHz harmonic
Description
Bland Altman-derived bias in VoA-based IPH size measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD bias for IPH size at 12 MHz harmonic
Description
Bland Altman-derived bias in PD-based IPH size measurement at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
VoA prevalence of TRFC detection at 8 MHz fundamental
Description
prevalence of reader-detected TRFC from VoA at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of TRFC detection at 8 MHz fundamental
Description
prevalence of reader-detected TRFC from PD at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of TRFC detection at 12 MHz fundamental
Description
prevalence of reader-detected TRFC from VoA at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of TRFC detection at 12 MHz fundamental
Description
prevalence of reader-detected TRFC from PD at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of TRFC detection at 12 MHz harmonic
Description
prevalence of reader-detected TRFC from VoA at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD prevalence of TRFC detection at 12 MHz harmonic
Description
prevalence of reader-detected TRFC from PD at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
VoA prevalence of LRNC detection at 8 MHz fundamental
Description
prevalence of reader-detected LRNC from VoA at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of LRNC detection at 8 MHz fundamental
Description
prevalence of reader-detected LRNC from PD at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of LRNC detection at 12 MHz fundamental
Description
prevalence of reader-detected LRNC from VoA at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of LRNC detection at 12 MHz fundamental
Description
prevalence of reader-detected LRNC from PD at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of LRNC detection at 12 MHz harmonic
Description
prevalence of reader-detected LRNC from VoA at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD prevalence of LRNC detection at 12 MHz harmonic
Description
prevalence of reader-detected LRNC from PD at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
VoA prevalence of IPH detection at 8 MHz fundamental
Description
prevalence of reader-detected IPH from VoA at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of IPH detection at 8 MHz fundamental
Description
prevalence of reader-detected IPH from PD at 8 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of IPH detection at 12 MHz fundamental
Description
prevalence of reader-detected IPH from VoA at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
PD prevalence of IPH detection at 12 MHz fundamental
Description
prevalence of reader-detected IPH from PD at 12 MHz fundamental frequency
Time Frame
During the procedure
Title
VoA prevalence of IPH detection at 12 MHz harmonic
Description
prevalence of reader-detected IPH from VoA at 12 MHz harmonic frequency
Time Frame
During the procedure
Title
PD prevalence of IPH detection at 12 MHz harmonic
Description
prevalence of reader-detected IPH from PD at 12 MHz harmonic frequency
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 years or older having 50-99% stenotic symptomatic carotid plaque with clinical indication for endarterectomy having 50-69% stenotic asymptomatic carotid plaque without clinical indication for endarterectomy Exclusion Criteria: prior CEA or carotid stenting carotid occlusion vasculitis malignancy inability to provide informed consent prior radiation therapy to the neck treatment with immunomodulating drugs oncological disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melrose Fisher, RN
Phone
919-819-9054
Email
mwfisher54@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Gallippi, PhD
Phone
919-843-6647
Email
cmgallip@email.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Gallippi, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melrose W Fisher, R.N.
Phone
919-819-9054
Email
melrosef@email.unc.edu
First Name & Middle Initial & Last Name & Degree
Caterina M Gallippi, Ph.D.
Phone
919-843-6647
Email
cmgallip@email.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data pertaining to the study protocol and the statistical analysis plan that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Deidentified individual data pertaining to the study protocol and the statistical analysis plan that support the results will be shared beginning 9 to 36 months following publication.
IPD Sharing Access Criteria
An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

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Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk

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