CT Evaluation of Carotid Plaque Components

Recruiting now

Conditions studied: Carotid Plaque

In brief

The goal of this observational study is to validate the diagnostic performance of photon counting/spectral CT to distinguish tissue components in ischemic stroke with MRI, semi-automated segmentation software or histology as the reference standard. The main question\[s\] it aims to answer are: 1. Presence or absence of calcium, hemorrhage, and lipid plaque components as determined on CT will be confirmed with carotid MRI, segmentation quantitative (e.g., volume) output from segmentation software, or histologic staining. 2. Volumes of hemorrhage, lipid, and calcium components will be measured to determine plaque phenotype and correlated with ipsilateral intracranial stroke burden. Participants will be asked to do the following: Aim 1: * 1 Photon counting/spectral CT angiography of the neck * 1 Research Carotid/Neck MRI of the carotid arteries (if eligible) Aim 2: * 1 Research Carotid/Neck MRI of the carotid arteries (if eligible) * 1 Photon counting/spectral CT angiography of the neck * 1 Carotid plaque tissue from participants surgery will be retrieved, imaged, and stained (if eligible)

Key facts

Study ID

NCT05764772

Run by

University of Pennsylvania

People needed

70

Starts

2023-10-01

Expected to finish

2028-12-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with symptomatic carotid stenosis with ipsilateral ischemic infarcts attributable to the carotid disease
• At least 1mm of noncalcified plaque on same side of stroke
• Brain MRI documenting ischemic infarct in distribution attributable to ipsilateral carotid disease
• Patients planned to undergo carotid endarterectomies
• Patients must be able to read and understand English
• Participants must sign the informed consent form

You may not qualify if…

• Exclusion Criteria
• Patients less than 18 years old
• Women who are pregnant and/or nursing

Where it is running

• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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