CT Evaluation of Carotid Plaque Components

Carotid Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764772
• Other study ID #: 852646
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 2028

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Marisa Sanchez
• Phone: 215-901-9994
• Email: Marisa.Sanchez[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 and 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 Research Carotid/Neck MRI of the carotid arteries

• 1 Photon counting/spectral CT angiography of the neck

Aim 2:

• 1 Research Carotid/Neck MRI of the carotid arteries

• 1 Photon counting/spectral CT angiography of the neck

• 1 Carotid plaque tissue from participants surgery will be retrieved, imaged, and stained

Description:

Independent of the degree of stenosis, specific features of carotid plaque composition are associated with a high risk of thromboembolic and recurrent stroke. Many lines of evidence show a significant association between the presence of intraplaque hemorrhage and lipid rich necrotic core in carotid plaque independent of vessel stenosis in patients with ipsilateral ischemic infarcts. In fact, up to 17% of ischemic strokes are classified as embolic stroke of undetermined source (ESUS) after a comprehensive diagnostic work-up. A subset of these patients have stroke due to mildly stenotic plaque composed of high-risk non-calcified carotid plaque components that are presently difficult to distinguish by noninvasive conventional imaging tests. Presently first-line imaging of acute stroke patients is computed tomography angiography (CTA) of the head and neck. Although conventional CTA provides information about stenosis, it lacks the ability to distinguish tissue components with similar attenuation curves (e.g., lipid and intraplaque hemorrhage). Thus, invaluable diagnostic information is lost due to limitations of conventional CTA. By contrast, photon-counting/spectral CT is a novel technology that can identify material-specific characteristics and identify plaque components (e.g., iron/hemorrhage, lipid, and calcium) based on the specific behavior of these materials at different photon energy levels.

The investigators propose testing the diagnostic performance of this new CT technology to detect different plaque components in subjects who are medically managed by carotid MRI and postprocessing PCCT images using a semi-automated carotid plaque segmentation software. The investigators also propose testing the diagnostic performance of this new CT technology in patients undergoing carotid endarterectomy revascularization surgery as standard of care with carotid MRI and histologic validation of the resected plaque tissue (ground truth).

Accurate detection of these high-risk noncalcified plaque components by noninvasive imaging methods would be of great value to identifying a patient population at highest risk for embolic stroke from carotid disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2028
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Exclusion Criteria

• Patients less than 18 years old

• Women who are pregnant and/or nursing

Related Conditions & MeSH terms

• Carotid Plaque

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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