Cardiac Allograft Vasculopathy
Conditions
Keywords
Heart transplantation, Cardiac allograft vasculopathy, photon counting computed tomography, Invasive coronary angiography, Intravascular ultrasound
Brief summary
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.
Detailed description
Cardiac allograft vasculopathy (CAV) is a major cause of graft failure and mortality in heart transplant recipients. Unlike traditional atherosclerosis, CAV is characterized by diffuse intimal hyperplasia and concentric narrowing of coronary arteries, affecting both epicardial vessels and the microvasculature. The cause is largely unknown, although it is believed that both immunologic and non-immunologic factors could be at play. CAV is frequently asymptomatic due to denervation of the transplanted heart, underscoring the importance of routine surveillance to enable early and accurate detection. Such monitoring is essential to optimize post-transplant outcomes. Invasive coronary angiography (ICA) is the gold standard for diagnosing CAV, while intravascular ultrasound (IVUS) can be considered as the gold standard for the assessment of intimal thickening and plaque burden. Photon-counting computed tomography (PCCT) represents a novel, non-invasive imaging modality with superior spatial resolution and tissue contrast compared to conventional CT systems. A systematic comparison of PCCT with ICA and IVUS for detecting CAV has not yet been performed. This study aims to assess the diagnostic accuracy, clinical relevance, and cost-effectiveness of PCCT in comparison to ICA and IVUS. By evaluating the advantages and limitations of non-invasive versus invasive modalities, the study seeks to define the optimal surveillance strategy for CAV, ultimately guiding the management of heart transplant recipients and improving long-term outcomes.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Adult heart transplant recipients. * Clinically stable and scheduled for routine ICA. * Ability to provide informed consent
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of agreement between PCCT and ICA in grading CAV severity | 2 days | Non-invasive investigation compared with invasive procedures |
| Diagnostic accuracy of PCCT compared to ICA in detecting CAV | 2 days | Non-invasive investigation compared to invasive procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose exposure using PCCT contra ICA/IVUS. | 2 days | Radiation dose compared between PCCT and ICA/IVUS |
| Patient comfort and procedural time differences with PCCT versus IVA/IVUS | 2 days | Comparing patient comfort during PCCT and ICA/IVUS, respectively |
| Cost-effectiveness of PCCT versus ICA/IVUS | 2 days | The cost of PCCT verus ICA/IVUS |
| Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden. | 2 days | PCCT compared with IVUS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relationship between CAV and periarterial fat density as well as myocardial fibrosis | 1 day | To see whether periarterial fat density and myocardial fibrosis are related to CAV |
Countries
Sweden