ARFI Ultrasound for Stroke Risk Assessment in Carotid Artery Plaque

Recruiting in Palo Alto (17 mi)

Overseen byCaterina Gallippi, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with carotid artery plaque that's causing a narrowing (stenosis) of 50-99% and showing symptoms, or a narrowing of 50-69% without symptoms and no need for surgery. People can't join if they can't consent, had neck radiation, cancer, blood vessel inflammation, previous carotid surgery or stenting, complete blockage in the carotid artery, or are on immune-altering drugs.

Inclusion Criteria

I have a partially blocked carotid artery but no symptoms.

I am 18 years old or older.

I have a significantly narrowed artery in my neck that needs surgery.

Exclusion Criteria

I am currently taking drugs that affect my immune system.

I have had radiation therapy to my neck before.

I have a blocked carotid artery.

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Participant Groups

The study is testing an ultrasound technology called Acoustic Radiation Force Impulse (ARFI). It aims to identify patients at high risk of stroke by noninvasively imaging the plaques in their carotid arteries to see if they might cause a stroke.

4Treatment groups

Experimental Treatment

Group I: Symptomatic with 70-99% stenosisExperimental Treatment1 Intervention

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.

Group II: Symptomatic with 50-69% stenosisExperimental Treatment1 Intervention

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.

Group III: Asymptomatic with 70-99% stenosisExperimental Treatment1 Intervention

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.

Group IV: Asymptomatic with 50-69% stenosisExperimental Treatment1 Intervention

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