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Perflutren for Carotid Artery Disease

Phase 4
Waitlist Available
Led By Kibo Nam, PhD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-endarterectomy
Awards & highlights

Study Summary

This trial looks at plaque vulnerability in carotid arteries non-invasively using ultrasound and pressure estimation techniques to measure plaque cap pressure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to Perflutren such as allergy symptoms if sensitive. Since it's an imaging procedure involving ultrasound contrast agent rather than medication intake, fewer systemic side effects are expected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-endarterectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-endarterectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between the pressure gradient and surrogate (imaging and histological) predictors

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carotid SHAPE estimationExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren
2012
N/A
~40

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,694 Total Patients Enrolled
Kibo Nam, PhDPrincipal InvestigatorThomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound
2020. "Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04643431.
All > Atherosclerosis
~5 spots leftby Apr 2025
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