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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.