Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk
Status: Active_not_recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
The University of North Carolina at Chapel Hill Hospitals
Chapel Hill
Time Frame
Start Date: 2019-07-17
Completion Date: 2025-11
Participants
Target number of participants: 80
Treatments
Experimental: Symptomatic with 50-69% stenosis
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.
Experimental: Symptomatic with 70-99% stenosis
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.
Experimental: Asymptomatic with 70-99% stenosis
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.
Experimental: Asymptomatic with 50-69% stenosis
Patients 18 years of age or older who have been diagnosed with 50-69% carotid artery stenosis without clinical indication for CEA.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)