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

Johannes Gutenberg University (JGU)

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT05877768

PCD-CT Registry

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

3,000 participants in 1 patient group

Coronary Artery Disease

Description:

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.

Treatment:

Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography