About this trial
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
This trial does not accept healthy volunteersQualifiers
Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
Written informed consent
Disqualifiers
Contraindications preventing the execution of the CCTA (e.g., pregnancy)
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Photon Counting Detector Coronary Computed Tomography Angiography
Diagnostic testClinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
Objective Assessment of Noise-Power Spectra of PCD-CCTA
Image Noise of PCD-CCTA measured objectively using noise-power spectra (W/Hz).
Subjective Image Noise of PCD-CCTA
Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale.
Objective Vessel sharpness in PCD-CCTA
Vessel sharpness in PCD-CCTA measured objectively using the slope of fitted double sigmoid curves (1/mm)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: