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

NCT04643431 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Kibo Nam, PhD · Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-04-05
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643431 on ClinicalTrials.gov