Perflutren for Carotid Artery Disease

Overseen By Diana Zaccagnini

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Disqualifiers: Pregnancy, Medically unstable, Recent surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method for assessing pressure differences in the carotid artery, which can help determine the risk level of plaque buildup. The treatment uses an ultrasound contrast agent called Perflutren to measure these differences non-surgically. Individuals with atherosclerosis who plan to undergo a procedure to remove plaque from their carotid artery might be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for a broader range of patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have recently received any contrast medium for imaging tests, you may need to wait 24 hours before participating.

What is the safety track record for Perflutren?

Research has shown that perflutren is generally safe for people. Previous studies found that this ultrasound contrast agent is well-tolerated. It is used in a simple procedure to create images of carotid artery plaques, which are buildups in the artery that can cause blockages.

Contrast-enhanced ultrasound, which uses perflutren, is considered a safe way to check these plaques. This method is helpful because it doesn't involve surgery or other invasive procedures.

While no treatment is completely without risk, evidence so far suggests that perflutren is safe for imaging. For personalized information, discussing any concerns with the trial team or a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for carotid artery disease focus on reducing plaque buildup or managing symptoms through medications like statins and antiplatelet agents. But Perflutren works differently, as it is used as a contrast agent in ultrasound imaging to enhance the assessment of plaque characteristics. Researchers are excited about this treatment because it allows for detailed 3D imaging of the plaque, which could help in accurately evaluating its stability and potential risk. This innovative approach might lead to more precise and personalized treatment plans for patients.

What evidence suggests that this pressure estimation technique is effective for carotid artery disease?

Studies have shown that perflutren, when used in contrast-enhanced ultrasound, helps detect changes in the carotid arteries related to heart disease. Research indicates that new blood vessels forming within plaque (a build-up in the arteries) can predict future heart problems. In patients with carotid atherosclerosis (a type of artery disease), these ultrasound signals are stronger and relate to thicker artery walls. The trial will use perflutren in the "Carotid SHAPE estimation" arm to assess its effectiveness in identifying risky plaques that might lead to heart issues. Overall evidence supports its effectiveness in assessing and managing carotid artery disease. ^{1 6 7 8 9}

Who Is on the Research Team?

Kibo Nam, PhD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with atherosclerosis who are scheduled for carotid endarterectomy. It's not suitable for pregnant or breastfeeding individuals, those allergic to perflutren, patients with unstable heart conditions, recent cerebral hemorrhage, critical care patients, or those on life support.

Inclusion Criteria

You are scheduled to have surgery to remove blockages in your carotid arteries due to a condition called atherosclerosis.

Exclusion Criteria

You have recently had bleeding in your brain.

You have a condition called unstable occlusive disease, which includes symptoms like severe chest pain.

Pregnancy or breast-feeding at the time of the scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo SHAPE estimation using 3D contrast-enhanced ultrasound to assess carotid plaque pressure gradients

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perflutren

Trial Overview The study tests a technique called SHAPE using contrast-enhanced ultrasound (with Perflutren) to noninvasively estimate pressure gradients across plaque in the carotid artery and compare these estimates to markers of plaque vulnerability.

How Is the Trial Designed?

Group I: Carotid SHAPE estimation Experimental Treatment 1 Intervention

The ultrasound contrast agent is infused (4-10 mL/min). An area within the plaque demonstrating internal flow is selected and a software based calibration algorithm is executed. After selecting the optimal acoustic output power 3D SHAPE volumes of the entire plaque (including the carotid artery) are acquired. Infusion is stopped and after microbubble clearance a second set of 3D SHAPE volumes (without contrast) are obtained.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6806260/

Carotid intraplaque neovascularization predicts coronary ... Carotid plaque neovascularization was found to be predictive of significant and complex CAD and future CV events.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9939062/

Evidence of Carotid Atherosclerosis Vulnerability ... MRC European carotid surgery trial: interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis.

3. researchgate.net researchgate.net/publication/23224216_Contrast-enhanced_ultrasound_imaging_of_periadventitial_vasa_vasorum_in_human_carotid_arteries

Contrast-enhanced ultrasound imaging of periadventitial ... Periadventitial contrast signal was detected in all patients and BFI thickness was higher in patient with carotid atherosclerosis and correlated ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666350322000724

A narrative review on the application of high-intensity ... In current preclinical and clinical data, the safety and efficacy of HIFU shows great promise in the treatment of atherosclerotic arterial disease.

5. researchgate.net researchgate.net/publication/38086672_Vasa_Vasorum_and_Plaque_Neovascularization_on_Contrast-Enhanced_Carotid_Ultrasound_Imaging_Correlates_With_Cardiovascular_Disease_and_Past_Cardiovascular_Events

Vasa Vasorum and Plaque Neovascularization on Contrast ... Multivariate logistic regression analysis revealed that presence of plaque was significantly associated with CVD (odds ratio 4.7, 95% CI 1.6 to ...

6. withpower.com withpower.com/trial/phase-4-carotid-artery-diseases-11-2020-80cd2

Perflutren for Carotid Artery Disease · Info for Participants Prior Safety DataThis treatment has passed at least one previous human trial ... plaque and the carotid artery) to imaging and histology markers of plaque ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07178015

Analysis of the Vulnerability of Carotid Artery Plaques | ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

8. ajronline.org ajronline.org/doi/pdf/10.2214/AJR.11.7312

Contrast-Enhanced Ultrasound for Assessing Carotid ... Contrast-enhanced ultrasound is a new, noninvasive, and safe proce- dure for imaging carotid atherosclerotic lesions. It is a valuable tool for evaluating the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9515377/

Detecting vulnerable carotid plaque and its component ... Carotid atherosclerotic plaque rupture and thrombosis are independent risk factors for acute ischemic cerebrovascular disease.