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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Photon Counting Detector Coronary Computed Tomography Angiography

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Tilman Emrich, MD; Phone Number: 7358 +49613117; Email: Tilman.Emrich@unimedizin-mainz.de
• Study Contact Backup: Name: Moritz C Halfmann, MD; Phone Number: 5719 +49613117; Email: Moritz.Halfmann@unimedizin-mainz.de

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55116
      • University Medical Center Mainz
      • Contact: Tilman Emrich, MD; Phone Number: 7358 +49613117; Email: Tilman.Emrich@unimedizin-mainz.de
      • Contact: Moritz C Halfmann, MD; Phone Number: 5719 +49613117; Email: Moritz.Halfmann@unimedizin-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population screened for inclusion criteria will be patients referred for CCTA for suspected coronary artery disease and those with known coronary artery disease and the suspicion of progressive disease.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Coronary Artery Disease; 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; Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.; Other Names: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medical Center Mainz
• Investigators: Principal Investigator: Tilman Emrich, MD, University Medical Center Mainz

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): June 30, 2033
• Study Completion (Estimated): June 30, 2033

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PCD-CT Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No