Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease

Study Overview
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Brief Summary
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The goal of this observational study is to learn about a new type of computed tomography (Photon-Counting Detector CT) in patients with coronary artery disease. The main questions it aims to answer are: How good is the image quality for the new CT How accurate are measurements in the images of the new CT Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations) Is there a relationship between measurements in the images and the results of follow-up investigations Is there a relationship between measurements in the images and the patient outcome Participants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.

Official Title
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PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof Written informed consent Exclusion Criteria: Contraindications preventing the execution of the CCTA (e.g., pregnancy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease<br>Patients with suspected coronary artery disease and those with known coronary artery disease and the suspicion of progressive disease who undergo clinically indicated Coronary Computed Tomography Angiography on the Photon-Counting Detector CT will be enrolled after written consent. All data from the CT scan and potential additional investigations (e.g. invasive coronary angiographies) will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire. | Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography<br>* Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.<br>* Other names: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. | From inclusion to a maximum follow-up of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA) | Image Noise of PCD-CCTA measured objectively using measurements of CT values (HU). | during the PCD-CCTA examination | 
| Objective Assessment of Noise-Power Spectra of PCD-CCTA | Image Noise of PCD-CCTA measured objectively using noise-power spectra (W/Hz). | during the PCD-CCTA examination | 
| Subjective Image Noise of PCD-CCTA | Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale. | during the PCD-CCTA examination | 
| Objective Vessel sharpness in PCD-CCTA | Vessel sharpness in PCD-CCTA measured objectively using the slope of fitted double sigmoid curves (1/mm) | during the PCD-CCTA examination | 
| Subjective Vessel sharpness in PCD-CCTA | Vessel sharpness in PCD-CCTA judged subjectively on a 5-point Likert scale. | during the PCD-CCTA examination | 
| Objective Image Quality in PCD-CCTA | Objective Image Quality in PCD-CCTA measured objectively by contrast-to-noise ratio (HU/HU) | during the PCD-CCTA examination | 
| Subjective Image Quality in PCD-CCTA | Subjective Image Quality in PCD-CCTA judged subjectively on a 5-point Likert scale. | during the PCD-CCTA examination | 
| Influence of BMI on image quality of the PCD-CCTA | Influence of Body Mass Index (BMI, kg/m^2) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of biological sex on image quality of the PCD-CCTA | Influence of patients biological sex (male/female) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of monoenergetic energy levels on image quality of the PCD-CCTA | Influence of monoenergetic energy levels (keV) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of slice thickness of reconstruction on image quality of the PCD-CCTA | Influence of slice thickness of reconstruction (mm) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of reconstruction kernel on image quality of the PCD-CCTA | Influence of reconstruction kernel (Bv/Br/Qr) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of kernel sharpness level on image quality of the PCD-CCTA | Influence of kernel sharpness level (40-90) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of radiation dose on image quality of the PCD-CCTA | Influence of radiation dose (mGy) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of the patients heart rate on image quality of the PCD-CCTA | Influence of the patients maximum, minimum and average heart rate (1/min) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of the acquisition type on image quality of the PCD-CCTA | Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on image quality of the PCD-CCTA | during the PCD-CCTA examination | 
| Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA | Quantitative analysis of Coronary Calcium volume (mm^3), mass (g) and resulting score according to the Agatston classification. | during the PCD-CCTA examination | 
| Analysis of Stenosis Classification from PCD-CCTA | Analysis of Coronary stenosis classification according to the Coronary Artery Disease-Reporting and Data System (CAD-RADS, 0-5, higher numbers indicating more severe stenosis). | during the PCD-CCTA examination | 
| Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA | Quantitative analysis of Coronary Diameter Stenoses (%) from PCD-CCTA | during the PCD-CCTA examination | 
| Quantitative analysis of Coronary Area Stenoses from PCD-CCTA | Quantitative analysis of Coronary Area Stenoses (%) from PCD-CCTA | during the PCD-CCTA examination | 
| Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA | Quantitative analysis of computed Fractional Flow Reserve (absolute number) from PCD-CCTA. | during the PCD-CCTA examination | 
| Quantitative analysis of myocardial density from PCD-CCTA | Quantitative analysis of myocardial density (HU) from PCD-CCTA. | during the PCD-CCTA examination | 
| Quantitative analysis of myocardial iodine content from PCD-CCTA | Quantitative analysis of myocardial iodine content (µg/cm^3) from PCD-CCTA. | during the PCD-CCTA examination | 
| Quantitative analysis of extracellular volume fraction from PCD-CCTA | Quantitative analysis of the extracellular volume fraction (%) from PCD-CCTA. | during the PCD-CCTA examination | 
| Influence of BMI on quantitative parameters of the PCD-CCTA | Influence of Body Mass Index (BMI, kg/m^2) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of biological sex on quantitative parameters of the PCD-CCTA | Influence of patients biological sex (male/female) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA | Influence of monoenergetic energy levels (keV) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA | Influence of slice thickness of reconstruction (mm) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA | Influence of reconstruction kernel (Bv/Br/Qr) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA | Influence of kernel sharpness level (40-90) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of radiation dose on quantitative parameters of the PCD-CCTA | Influence of radiation dose (mGy) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of the patients heart rate on quantitative parameters of the PCD-CCTA | Influence of the patients maximum, minimum and average heart rate (1/min) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Influence of the acquisition type on quantitative parameters of the PCD-CCTA | Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on quantitative parameters of the PCD-CCTA | during the PCD-CCTA examination | 
| Rates of patients undergoing further cardiac diagnostics | Rates of patients undergoing further cardiac diagnostics, such as additional CT or Invasive Coronary Angiography (ICA), Electrocardiography (ECG), Exercise ECG, Echo, Stress Echo, Magnetic Resonance Imaging (MRI) within 3 months following PCD-CCTA (defined as: related to these tests) and more than 3 months after PCD-CCTA until follow-up (unrelated to these tests). | 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years | 
| Rates of patients undergoing cardiac interventions | Cardiac interventions such as coronary revascularization by ICA, coronary artery bypass grafting (CABG), Valve replacement (operatively and interventional), other cardiothoracic surgeries, implantation of an cardioverter/defibrillator or cardiac resynchronization device, ablation, others | 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years | 
| Correlation and agreement of quantitative measurements from PCD-CCTA with ICA | Correlation and agreement of percent diameter stenosis quantification by PCD-CCTA in comparison to quantitative assessment from ICA. | ICA within 3 months of initial PCD-CCTA | 
| Correlation and agreement of non-invasive Fractional Flow Reserve from PCD-CCTA with invasive Fractional Flow Reserve from ICA | Correlation and agreement of non-invasively estimated Fractional Flow Reserve by Computed Tomography with invasive Fractional Flow Reserve | ICA within 3 months of initial PCD-CCTA | 
| Correlation and agreement of Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA | Correlation and agreement of stenosis quantification by PCD-CCTA and invasive Fractional Flow Reserve. | ICA within 3 months of initial PCD-CCTA | 
| Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques | Correlation and agreement of Plaque composition assessment from PCD-CCTA in comparison to intracoronary techniques such as optical coherence tomography (OCT) in patients who had both tests done. | ICA within 3 months of initial PCD-CCTA | 
| Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests | Correlation of quantitative PCD-CCTA parameters with imaging ischemia tests in patients who had both PCD-CCTA and one of the following tests done: stress echo, stress Single Photon Emission Computed Tomography (SPECT), stress Positron Emission Tomography (PET), and stress MRI. | Imaging ischemia tests within 3 months of initial PCD-CCTA | 
| Correlation of quantitative PCD-CCTA parameters with the results of additional other imaging tests | Correlation of quantitative PCD-CCTA parameters with imaging tests in patients who had both PCD-CCTA and one of the following tests done: transthoracic echo, transesophageal echo, cardiac MRI. | Imaging tests within 3 months of initial PCD-CCTA | 
| Patient management | Recommended and actually performed management based on PCD-CCTA | at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years | 
| Analysis of occurrence in Major Adverse Cardiac Events in subgroups | Composite outcome: Analysis of occurrence in MACE as a secondary outcome in following subgroups: CT plaque characteristic groups: high risk versus other plaques versus no plaques; Plaque burden groups: P1 vs. P2 vs. P3 vs. P4 according to the CAD-RADS 2.0 classification; Gender: male versus female; Age: occurrence of MACE in patient a) under 45 years, b) between 45 and 65 years and c) over 65 years; BMI: Patients with BMI a) under 25, b) between 25 and 30 and c) over 30; | at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years |