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

Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Image Noise of PCD-CCTA measured objectively using measurements of CT values (HU).

Image Noise of PCD-CCTA measured objectively using noise-power spectra (W/Hz).

Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale.

Vessel sharpness in PCD-CCTA measured objectively using the slope of fitted double sigmoid curves (1/mm)

Vessel sharpness in PCD-CCTA judged subjectively on a 5-point Likert scale.

Objective Image Quality in PCD-CCTA measured objectively by contrast-to-noise ratio (HU/HU)

Subjective Image Quality in PCD-CCTA judged subjectively on a 5-point Likert scale.

Influence of Body Mass Index (BMI, kg/m^2) on image quality of the PCD-CCTA

Influence of patients biological sex (male/female) on image quality of the PCD-CCTA

Influence of monoenergetic energy levels (keV) on image quality of the PCD-CCTA

Influence of slice thickness of reconstruction (mm) on image quality of the PCD-CCTA

Influence of reconstruction kernel (Bv/Br/Qr) on image quality of the PCD-CCTA

Influence of kernel sharpness level (40-90) on image quality of the PCD-CCTA

Influence of radiation dose (mGy) 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

Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on image quality of the PCD-CCTA

Quantitative analysis of Coronary Calcium volume (mm^3), mass (g) and resulting score according to the Agatston classification.

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).

Quantitative analysis of Coronary Diameter Stenoses (%) from PCD-CCTA

Quantitative analysis of Coronary Area Stenoses (%) from PCD-CCTA

Quantitative analysis of computed Fractional Flow Reserve (absolute number) from PCD-CCTA.

Quantitative analysis of myocardial density (HU) from PCD-CCTA.

Quantitative analysis of myocardial iodine content (µg/cm^3) from PCD-CCTA.

Quantitative analysis of the extracellular volume fraction (%) from PCD-CCTA.

Influence of Body Mass Index (BMI, kg/m^2) on quantitative parameters of the PCD-CCTA

Influence of patients biological sex (male/female) on quantitative parameters of the PCD-CCTA

Influence of monoenergetic energy levels (keV) on quantitative parameters of the PCD-CCTA

Influence of slice thickness of reconstruction (mm) on quantitative parameters of the PCD-CCTA

Influence of reconstruction kernel (Bv/Br/Qr) on quantitative parameters of the PCD-CCTA

Influence of kernel sharpness level (40-90) on quantitative parameters of the PCD-CCTA

Influence of radiation dose (mGy) 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

Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on quantitative parameters of the PCD-CCTA

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).

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

Correlation and agreement of percent diameter stenosis quantification by PCD-CCTA in comparison to quantitative assessment from ICA.

Correlation and agreement of non-invasively estimated Fractional Flow Reserve by Computed Tomography with invasive Fractional Flow Reserve

Correlation and agreement of stenosis quantification by PCD-CCTA and invasive Fractional Flow Reserve.

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.

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.

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.

Recommended and actually performed management based on PCD-CCTA

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;