CT Evaluation of Carotid Plaque Components
ConditionCarotid Plaque
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Exclusion Criteria
Patients less than 18 years old
Women who are pregnant and/or nursing
Trial population
Patients presenting with acute stroke or transient ischemic attacks and stenosis of the ipsilateral carotid artery will be identified and eligible patients will be screened and consented for study participation in a multi-disciplinary effort by Vascular Neurology (contact: Dr. Brett Cucchiara), Vascular Surgery (contact: Dr. Grace Wang), and Diagnostic Radiology (contact: Dr. Jae W. Song).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To validate the diagnostic performance of photon counting/spectral CT
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.
Time frame
3yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov