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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.
University Medical Center Mainz
Mainz, Rhineland-Palatinate, Germany
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.
Time frame: From inclusion to a maximum follow-up of 5 years
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).
Time frame: 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).
Time frame: during the PCD-CCTA examination
Subjective Image Noise of PCD-CCTA
Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale.
Time frame: 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)
Time frame: during the PCD-CCTA examination
Subjective Vessel sharpness in PCD-CCTA
Vessel sharpness in PCD-CCTA judged subjectively on a 5-point Likert scale.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: during the PCD-CCTA examination
Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA
Quantitative analysis of Coronary Diameter Stenoses (%) from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of Coronary Area Stenoses from PCD-CCTA
Quantitative analysis of Coronary Area Stenoses (%) from PCD-CCTA
Time frame: 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.
Time frame: during the PCD-CCTA examination
Quantitative analysis of myocardial density from PCD-CCTA
Quantitative analysis of myocardial density (HU) from PCD-CCTA.
Time frame: 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.
Time frame: during the PCD-CCTA examination
Quantitative analysis of extracellular volume fraction from PCD-CCTA
Quantitative analysis of the extracellular volume fraction (%) from PCD-CCTA.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Imaging tests within 3 months of initial PCD-CCTA
Patient management
Recommended and actually performed management based on PCD-CCTA
Time frame: 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;
Time frame: at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
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