Clinical trial NCT05877768: Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease
Official title: PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University Medical Center Mainz
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: From inclusion to a maximum follow-up of 5 years
Secondary outcomes:
measure: Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA)
timeFrame: during the PCD-CCTA examination
measure: Objective Assessment of Noise-Power Spectra of PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Subjective Image Noise of PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Objective Vessel sharpness in PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Subjective Vessel sharpness in PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Objective Image Quality in PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Subjective Image Quality in PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of BMI on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of biological sex on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of monoenergetic energy levels on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of slice thickness of reconstruction on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of reconstruction kernel on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of kernel sharpness level on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of radiation dose on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of the patients heart rate on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of the acquisition type on image quality of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Analysis of Stenosis Classification from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of Coronary Area Stenoses from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of myocardial density from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of myocardial iodine content from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Quantitative analysis of extracellular volume fraction from PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of BMI on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of biological sex on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of radiation dose on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of the patients heart rate on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Influence of the acquisition type on quantitative parameters of the PCD-CCTA
timeFrame: during the PCD-CCTA examination
measure: Rates of patients undergoing further cardiac diagnostics
timeFrame: 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
measure: Rates of patients undergoing cardiac interventions
timeFrame: 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
measure: Correlation and agreement of quantitative measurements from PCD-CCTA with ICA
timeFrame: ICA within 3 months of initial PCD-CCTA
measure: Correlation and agreement of non-invasive Fractional Flow Reserve from PCD-CCTA with invasive Fractional Flow Reserve from ICA
timeFrame: ICA within 3 months of initial PCD-CCTA
measure: Correlation and agreement of Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA
timeFrame: ICA within 3 months of initial PCD-CCTA
measure: Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques
timeFrame: ICA within 3 months of initial PCD-CCTA
measure: Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests
timeFrame: Imaging ischemia tests within 3 months of initial PCD-CCTA
measure: Correlation of quantitative PCD-CCTA parameters with the results of additional other imaging tests
timeFrame: Imaging tests within 3 months of initial PCD-CCTA
measure: Patient management
timeFrame: at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
measure: Analysis of occurrence in Major Adverse Cardiac Events in subgroups
timeFrame: at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Tilman Emrich, MD
role: PRINCIPAL_INVESTIGATOR
References: