About this trial
In traditional coronary artery disease, patients often experience symptoms such as angina. However, heart transplant patients lack nerve connections in the transplanted heart and therefore usually do not notice any symptoms. For this reason, routine examinations are performed using traditional coronary angiography at one, three, and six years after transplantation, sometimes with the addition of coronary ultrasound.
A new technique, photon-counting computed tomography, has now been developed and may potentially replace both traditional coronary angiography and intravascular ultrasound. In this study, we aim to investigate how well this method works in diagnosing coronary artery changes compared to the established methods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult heart transplant recipients.
Clinically stable and scheduled for routine ICA.
Ability to provide informed consent
Disqualifiers
Contrast allergy
Renal insufficiency with eGFR < 30 ml/min/m2
Other contraindications for PCCT, ICA, or IVUS
Acute cardiac events within 30 days prior to enrollment.
Trial population
Adult heart transplant recipients scheduled for routine coronary angiography
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of PCCT compared to ICA in detecting CAV
Non-invasive investigation compared to invasive procedures
Level of agreement between PCCT and ICA in grading CAV severity
Non-invasive investigation compared with invasive procedures
Secondary outcomes
Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.
PCCT compared with IVUS
Radiation dose exposure using PCCT contra ICA/IVUS.
Radiation dose compared between PCCT and ICA/IVUS
Cost-effectiveness of PCCT versus ICA/IVUS
The cost of PCCT verus ICA/IVUS
Patient comfort and procedural time differences with PCCT versus IVA/IVUS
Comparing patient comfort during PCCT and ICA/IVUS, respectively
Other outcomes
Relationship between CAV and periarterial fat density as well as myocardial fibrosis
To see whether periarterial fat density and myocardial fibrosis are related to CAV
Sponsors and contacts
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Sahlgrenska University Hospital
Lead sponsor
Göteborg University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: