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Recruiting NCT05764772

CT Evaluation of Carotid Plaque Components

Trial Parameters

Condition Carotid Plaque
Sponsor University of Pennsylvania
Study Type OBSERVATIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-01
Completion 2026-08

Brief Summary

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)

Eligibility Criteria

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

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