Skip to content

Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy

Comparing Photon Counting Computed Tomography With Invasive Coronary Angiography and Intravascular Ultrasound in Detecting Cardiac Allograft Vasculopathy

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07020039
Acronym
CAVIAR
Enrollment
100
Registered
2025-06-13
Start date
2025-09-01
Completion date
2027-08-31
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Allograft Vasculopathy

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

Göteborg University
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Level of agreement between PCCT and ICA in grading CAV severity2 daysNon-invasive investigation compared with invasive procedures
Diagnostic accuracy of PCCT compared to ICA in detecting CAV2 daysNon-invasive investigation compared to invasive procedures

Secondary

MeasureTime frameDescription
Radiation dose exposure using PCCT contra ICA/IVUS.2 daysRadiation dose compared between PCCT and ICA/IVUS
Patient comfort and procedural time differences with PCCT versus IVA/IVUS2 daysComparing patient comfort during PCCT and ICA/IVUS, respectively
Cost-effectiveness of PCCT versus ICA/IVUS2 daysThe cost of PCCT verus ICA/IVUS
Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.2 daysPCCT compared with IVUS

Other

MeasureTime frameDescription
Relationship between CAV and periarterial fat density as well as myocardial fibrosis1 dayTo see whether periarterial fat density and myocardial fibrosis are related to CAV

Countries

Sweden

Contacts

Primary ContactKristjan Karason, MD, PhD
kristjan.karason@vgregion.com+46 739401560
Backup ContactEntela Bollano, MD, PhD
entela.bollano@vgregion.se+46 70 7910635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026