Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk

NCT04063709 | Active Not Recruiting FDA Device

• 2 other identifiers: 17-2700R01HL092944-06A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque, Atherosclerotic; Carotid Artery Plaque; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Acoustic Radiation Force Impulse (ARFI) imaging

  Ability of ARFI imaging to detect carotid plaque features and measure their size

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

Secondary Outcomes (54)

• VoA AUC for thin or ruptured fibrous caps (TRFC) at 8 MHz fundamental

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

• PD AUC for TRFC at 8 MHz fundamental

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

• VoA AUC for TRFC at 12 MHz fundamental

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

• PD AUC for TRFC at 12 MHz fundamental

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

• VoA AUC for TRFC at 12 MHz harmonic

  Upon completion of the development of all novel ARFI data processing algorithms, their application to all acquired ARFI data, and the interpretation of the results for all participants, an average of two years

Study Arms (4)

Symptomatic with 50-69% stenosis

EXPERIMENTAL

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.

Diagnostic Test: Acoustic Radiation Force Impulse (ARFI) ultrasound

Symptomatic with 70-99% stenosis

EXPERIMENTAL

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.

Diagnostic Test: Acoustic Radiation Force Impulse (ARFI) ultrasound

Asymptomatic with 70-99% stenosis

EXPERIMENTAL

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.

Diagnostic Test: Acoustic Radiation Force Impulse (ARFI) ultrasound

Asymptomatic with 50-69% stenosis

EXPERIMENTAL

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

Diagnostic Test: Acoustic Radiation Force Impulse (ARFI) ultrasound

Interventions

Acoustic Radiation Force Impulse (ARFI) ultrasound DIAGNOSTIC_TEST

ARFI imaging is an ultrasound-based, noninvasive imaging method and will be used in accordance with approved labeling.

Asymptomatic with 50-69% stenosis; Asymptomatic with 70-99% stenosis; Symptomatic with 50-69% stenosis; Symptomatic with 70-99% stenosis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic; Carotid Stenosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Caterina Gallippi, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 21, 2019
• Study Start: July 17, 2019
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)