跳至主要内容
临床试验/NCT05764772
NCT05764772招募中不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
To validate the diagnostic performance of photon counting/spectral CT

研究概览

简要总结

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)

详细描述

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 or 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

To validate the diagnostic performance of photon counting/spectral CT

时间窗: 3years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae W. Song, MD, MS

Principal Investigator

University of Pennsylvania

研究点 (1)

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