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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Mainz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Photon Counting Detector Coronary Computed Tomography Angiography

    Diagnostic test

    Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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).

Time frame
during the PCD-CCTA examination
2

Objective Assessment of Noise-Power Spectra of PCD-CCTA

Image Noise of PCD-CCTA measured objectively using noise-power spectra (W/Hz).

Time frame
during the PCD-CCTA examination
3

Subjective Image Noise of PCD-CCTA

Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale.

Time frame
during the PCD-CCTA examination
4

Objective Vessel sharpness in PCD-CCTA

Vessel sharpness in PCD-CCTA measured objectively using the slope of fitted double sigmoid curves (1/mm)

Time frame
during the PCD-CCTA examination

Other outcomes

Sponsors and contacts

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