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NCT05764772Recruiting

CT Evaluation of Carotid Plaque Components

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

Source: ClinicalTrials.gov · Last updated 25 Nov 2025

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
10 Feb 2023
Start date
1 Oct 2023
Primary completion date
31 Aug 2026
Lead sponsor
University of Pennsylvania
Diseases
Stroke
NCT number
NCT05764772

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Oct 2023 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pennsylvania Hospital
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.