NCT04643431

Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound

Risk Assessment of Carotid Plaques Based on Pressure Estimation Using 3D Contrast-enhanced Ultrasound

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carotid Atherosclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Perflutren	The ultrasound contrast agent is used to improve the quality of ultrasound imaging and is infused over 5-10 minutes. The contrast agent consists of the gas-filled microbubbles smaller than the capillary size which circulate in the vascular system. The contrast agent is cleared from the body naturally within 30 minutes.

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-04-05
• Completion: 2025-12-31
• First posted: 2020-11-25
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study