- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07762664
Photon-Counting CT Versus Conventional CT for Carotid Plaque Assessment in Patients With Carotid Artery Stenosis
Prospective Comparison of Photon-Counting Detector CT and Conventional Energy-Integrating Detector CT for Carotid Atherosclerotic Plaque Assessment in Patients With Carotid Artery Stenosis
Study Overview
Status
Detailed Description
This prospective observational study aims to compare photon-counting detector computed tomography angiography (PCD-CTA) with conventional energy-integrating detector computed tomography angiography (EID-CTA) for the assessment of carotid atherosclerotic plaques in patients with carotid artery stenosis.
The study will evaluate differences between the two CT techniques in the visualization and quantitative characterization of carotid plaques, including plaque morphology, plaque burden, plaque components, calcification-related artifacts, and degree of carotid artery stenosis. Objective and subjective image quality will also be compared.
The study is intended to determine whether the improved spatial resolution and spectral imaging capabilities of photon-counting CT provide advantages over conventional CT for the characterization of carotid atherosclerotic disease.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jinhao Lyu, MD
- Phone Number: +8615903562929
- Email: 330322990@qq.com
Study Contact Backup
- Name: Jinying He
- Email: 1527012389@qq.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Jinhao Lyu, MD
- Phone Number: +8615903562929
- Email: 330322990@qq.com
-
Contact:
- Jinying He
- Phone Number: +8613854153820
- Email: 1527012389@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older.
- Patients with carotid atherosclerotic plaque or carotid artery stenosis.
- Patients scheduled to undergo carotid artery stenting.
- Patients undergoing preprocedural carotid CTA examination.
- Ability to provide written informed consent.
Exclusion Criteria:
- Known allergy to iodinated contrast material.
- Severe renal insufficiency or other contraindications to contrast-enhanced CT.
- Pregnancy or suspected pregnancy.
- Severe motion or other artifacts resulting in nondiagnostic image quality.
- Incomplete clinical or imaging data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients With Carotid Artery Stenosis
Patients with carotid artery stenosis who undergo preprocedural carotid CT angiography will be prospectively enrolled.
Carotid plaque characteristics and image quality will be evaluated and compared between photon-counting detector CT angiography and conventional energy-integrating detector CT angiography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Carotid Plaque Visualization and Characterization on PCD-CTA Compared With Conventional EID-CTA
Time Frame: 1-4 years
|
Carotid atherosclerotic plaques will be independently evaluated on photon-counting detector CTA and conventional energy-integrating detector CTA.
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1-4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contrast-to-noise ratio on PCD-CTA compared with conventional EID-CTA
Time Frame: 1-4years
|
Contrast-to-noise ratio (CNR) will be quantitatively calculated from measurements obtained on PCD-CTA and conventional EID-CTA using a predefined measurement method.
CNR values will be compared between the two CT techniques.
|
1-4years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Xin Lou, Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCD-CT Carotid Artery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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