Validation of Photon Counting/Spectral Computed Tomography Angiography of Carotid Plaque Composition in Patients with Ischemic Stroke

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pennsylvania Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Marisa Sanchez
Marisa.Sanchez@pennmedicine.upenn.edu
215-901-9994
Backup
Leeanne Lezotte
leeanne.lezotte@pennmedicine.upenn.edu
856-364-3137
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 70
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov