CT Evaluation of Carotid Plaque Components

NCT05764772 | Recruiting

• 1 other identifier: 852646
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Carotid Plaque

Outcome Measures

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.

  3years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

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:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Jae W Song

  University of Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Sanchez

CONTACT

215-901-9994; Marisa.Sanchez@pennmedicine.upenn.edu

Leeanne Lezotte

CONTACT

856-364-3137; leeanne.lezotte@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 13, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)