ARFI Ultrasound for Stroke Risk Assessment in Carotid Artery Plaque

Overseen By Caterina Gallippi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Immunomodulating drugs

Disqualifiers: Prior CEA, Carotid stenting, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound method to identify individuals at high risk of stroke. The focus is on using Acoustic Radiation Force Impulse (ARFI) ultrasound to examine carotid artery plaque, which can block blood flow and cause a stroke. Individuals with carotid artery narrowing (stenosis) between 50-99%, whether symptomatic or not, might be suitable candidates. The trial aims to improve early detection, enabling doctors to intervene before a stroke occurs. As an unphased trial, participants can contribute to groundbreaking research that could enhance early stroke detection and prevention.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunomodulating drugs, you cannot participate in the trial.

What prior data suggests that this ultrasound-based imaging technology is safe for stroke risk assessment?

Research has shown that Acoustic Radiation Force Impulse (ARFI) ultrasound is generally safe for people. Studies indicate that ARFI imaging is a noninvasive method using very gentle ultrasound waves, similar to other common ultrasound procedures. Available data confirm that the force of the waves in ARFI is much lower than levels that could cause harm.

Other studies have examined ARFI ultrasound in various conditions and found no major safety concerns. Although some animal studies have raised questions about high sound levels, these issues have not appeared in human studies. So far, no reports of negative effects in patients from ARFI ultrasound in similar situations have emerged. This makes ARFI ultrasound a promising and well-tolerated option for assessing stroke risk without exposing patients to significant danger. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Acoustic Radiation Force Impulse (ARFI) ultrasound because it offers a new method for assessing stroke risk in patients with carotid artery plaque. Unlike traditional methods, such as CT or MRI, which can be more invasive or require contrast agents, ARFI ultrasound uses sound waves to evaluate the stiffness of plaque in the carotid arteries. This non-invasive technique could provide more precise information about plaque stability and stroke risk without the need for radiation or dyes. If successful, ARFI ultrasound could become a safer, quicker, and more cost-effective option for evaluating patients at risk of stroke.

What evidence suggests that ARFI ultrasound is effective for stroke risk assessment?

Research has shown that a special type of ultrasound called Acoustic Radiation Force Impulse (ARFI) effectively identifies differences in carotid artery plaques. This trial will use ARFI ultrasound imaging on participants with varying degrees of carotid artery stenosis, both symptomatic and asymptomatic. Studies have found that ARFI distinguishes between the softer and harder parts of these plaques. This distinction is crucial because softer plaques can be more dangerous and might lead to strokes. ARFI provides clear images of the plaques, facilitating risk assessment without surgery or other invasive methods. This non-invasive technique has successfully examined plaque structures, showing promising results for assessing stroke risk. Overall, ARFI ultrasound could be a valuable tool in identifying patients at high risk for stroke prevention. ^{2 4 6 7 8}

Who Is on the Research Team?

Caterina Gallippi, PhD

Principal Investigator

UNC Chapel Hill

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Data Collection

ARFI ultrasound imaging is performed on carotid plaques to assess structure and composition.

8 weeks

4 visits (in-person)

Data Analysis

Development and application of ARFI data processing algorithms and interpretation of results.

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after imaging and data collection.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acoustic Radiation Force Impulse (ARFI) ultrasound

Trial Overview 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.

How Is the Trial Designed?

Group I: Symptomatic with 70-99% stenosis Experimental Treatment 1 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% stenosis Experimental Treatment 1 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% stenosis Experimental Treatment 1 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% stenosis Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5708537/

Performance of Acoustic Radiation Force Impulse ... This study suggests that ARFI is capable of distinguishing soft from stiff atherosclerotic plaque components and delineating FC thickness. Keywords: ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521417311515

Performance of acoustic radiation force impulse ultrasound ... This study suggests that acoustic radiation force impulse ultrasound is capable of distinguishing soft from stiff atherosclerotic plaque components and ...

3. withpower.com withpower.com/trial/arfi-ultrasound-for-stroke-risk-assessment-in-carotid-artery-plaque-9532c

ARFI Ultrasound for Stroke Risk Assessment in Carotid ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2813205/

ACOUSTIC RADIATION FORCE IMPULSE IMAGING FOR ... ARFI imaging was shown to be an effective, non-invasive technique for observing the mechanical makeup of carotid plaques.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0301562908005309

Acoustic Radiation Force Impulse Imaging for Noninvasive ... The goal of this study was to determine the feasibility of using ARFI imaging to generate high resolution images of carotid plaques in vivo. We employ ARFI ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0301562924004630

Safety of Shear Wave Elastography as Evidenced From ... Safety of Shear Wave Elastography as Evidenced From Carotid Artery Strain and Strain Rate Induced by Acoustic Radiation Force Impulse and Arterial Pulsations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4678151/

Comparison of Acoustic Radiation Force Impulse Imaging ... This work provides early evidence supporting the use of ARFI imaging to noninvasively identify lipid regions in carotid artery plaques in vivo that are believed ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/5084699

Shear Wave Elastography for the Assessment of Carotid ... Available data does not report any safety concerns of SWE, and the force of the wave pulse is known to be a thousand times lower compared to the ...