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ARFI Ultrasound for Stroke Risk Assessment in Carotid Artery Plaque

N/A

Recruiting

Led By Caterina Gallippi, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Having 50-99% stenotic symptomatic carotid plaque with clinical indication for endarterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the procedure

Awards & highlights

Study Summary

This trial is testing a new ultrasound technology to help identify people at high risk for stroke so that they can get timely intervention.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since ARFI ultrasound is noninvasive and uses sound waves to image tissues inside the body, it generally has minimal side effects which may include discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acoustic Radiation Force Impulse (ARFI) imaging

Secondary outcome measures

PD AUC for IPH at 12 MHz fundamental

PD AUC for IPH at 12 MHz harmonic

PD AUC for IPH at 8 MHz fundamental

+51 more

Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,514 Total Patients Enrolled

10 Trials studying Carotid Stenosis

114,705 Patients Enrolled for Carotid Stenosis

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,962 Total Patients Enrolled

1 Trials studying Carotid Stenosis

111,654 Patients Enrolled for Carotid Stenosis

Caterina Gallippi, PhDPrincipal InvestigatorUNC Chapel Hill

1 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

Acoustic Radiation Force Impulse (ARFI) ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT04063709 — N/A

Carotid Stenosis Research Study Groups: Symptomatic with 70-99% stenosis, Symptomatic with 50-69% stenosis, Asymptomatic with 70-99% stenosis, Asymptomatic with 50-69% stenosis

Carotid Stenosis Clinical Trial 2023: Acoustic Radiation Force Impulse (ARFI) ultrasound Highlights & Side Effects. Trial Name: NCT04063709 — N/A

Acoustic Radiation Force Impulse (ARFI) ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT04063709 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the research team recruiting for this investigation?

"Affirmative. Clinicaltrials.gov manifests that this investigation is actively recruiting participants; it was initially published on July 17th 2019 and last refreshed on April 27th 2022. Eighty individuals must be sourced from a single medical centre to take part in the trial."

Answered by AI

Is this research endeavor presently accepting applicants?

"Per the clinicaltrials.gov listing, this investigation is currently enrolling participants. The trial was initiated on July 17th 2019 and its information was most recently updated April 27th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk

2019. "Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04063709.