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

University Medical Center Mainz1 site in 1 country3,000 target enrollmentJune 30, 2023

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: University Medical Center Mainz
Enrollment: 3000
Locations: 1
Primary Endpoint: Major Adverse Cardiac Events
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2023

End Date

June 30, 2033

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Medical Center Mainz

Responsible Party

Principal Investigator

Tilman Emrich

Dr. med.

University Medical Center Mainz

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)

Outcomes

Primary Outcomes

Major Adverse Cardiac Events

Time Frame: From inclusion to a maximum follow-up of 5 years

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

Secondary Outcomes

Subjective Image Noise of PCD-CCTA(during the PCD-CCTA examination)
Objective Vessel sharpness in PCD-CCTA(during the PCD-CCTA examination)
Subjective Image Quality in PCD-CCTA(during the PCD-CCTA examination)
Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA(during the PCD-CCTA examination)
Subjective Vessel sharpness in PCD-CCTA(during the PCD-CCTA examination)
Objective Image Quality in PCD-CCTA(during the PCD-CCTA examination)
Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests(Imaging ischemia tests within 3 months of initial PCD-CCTA)
Correlation of quantitative PCD-CCTA parameters with the results of additional other imaging tests(Imaging tests within 3 months of initial PCD-CCTA)
Influence of slice thickness of reconstruction on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Influence of radiation dose 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(during the PCD-CCTA examination)
Influence of reconstruction kernel on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Influence of kernel sharpness level on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Influence of radiation dose on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Influence of the acquisition type on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Influence of the acquisition type on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Analysis of Stenosis Classification from PCD-CCTA(during the PCD-CCTA examination)
Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA(during the PCD-CCTA examination)
Quantitative analysis of Coronary Area Stenoses from PCD-CCTA(during the PCD-CCTA examination)
Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA(during the PCD-CCTA examination)
Rates of patients undergoing further cardiac diagnostics(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 Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA(ICA within 3 months of initial PCD-CCTA)
Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques(ICA within 3 months of initial PCD-CCTA)
Quantitative analysis of myocardial density from PCD-CCTA(during the PCD-CCTA examination)
Rates of patients undergoing cardiac interventions(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)
Patient management(at baseline, 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(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(ICA within 3 months of initial PCD-CCTA)
Quantitative analysis of myocardial iodine content from PCD-CCTA(during the PCD-CCTA examination)
Quantitative analysis of extracellular volume fraction from PCD-CCTA(during the PCD-CCTA examination)
Influence of BMI on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Influence of biological sex on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Analysis of occurrence in Major Adverse Cardiac Events in subgroups(at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years)
Objective Assessment of Noise-Power Spectra of PCD-CCTA(during the PCD-CCTA examination)
Influence of BMI on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA)(during the PCD-CCTA examination)
Influence of biological sex on image quality of the PCD-CCTA(during the PCD-CCTA examination)
Influence of monoenergetic energy levels 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(during the PCD-CCTA examination)
Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)