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ACTIVE NOT RECRUITING Phase 4

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

NCT04643431 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DIAGNOSTIC_TEST Perflutren

Study Locations (1)

Pennsylvania

  • Thomas jefferson University — Philadelphia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-12-01
Est. Completion 2025-12-31
Phase Phase 4

Sponsor

Thomas Jefferson University

324 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04643431

The ClinicalTrials.gov registry entry for NCT04643431 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carotid Atherosclerosis appearing as the primary indexed condition, and to 1 intervention — of which Perflutren is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04643431 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04643431 about?

NCT04643431 is a clinical study titled "Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound". 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 sig...

What is the current status of trial NCT04643431?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-12-01. Estimated completion is 2025-12-31.

What conditions does trial NCT04643431 study?

This clinical trial studies the following conditions: Carotid Atherosclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04643431?

The interventions under investigation include: Perflutren (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04643431?

This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04643431 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial