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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, non-randomized study conducted at Thomas Jefferson University comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. There is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. This pressure estimation technique (referred as SHAPE) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.

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.

Research Team

Kibo Nam, PhD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+