Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Allograft Vasculopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Photon Counting Computed Tomography With Invasive Coronary Angiography and Intravascular Ultrasound in Detecting Cardiac Allograft Vasculopathy
Overview
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.
Primary outcome measures
- Diagnostic accuracy of PCCT compared to ICA in detecting CAV [Time frame: 2 days]
- Level of agreement between PCCT and ICA in grading CAV severity [Time frame: 2 days]
Secondary outcome measures (4)
- Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden. [Time frame: 2 days]
- Radiation dose exposure using PCCT contra ICA/IVUS. [Time frame: 2 days]
- Cost-effectiveness of PCCT versus ICA/IVUS [Time frame: 2 days]
- Patient comfort and procedural time differences with PCCT versus IVA/IVUS [Time frame: 2 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Sweden · 1 center
- Transplant Institute — Gothenburg
Publications
- Pober JS, Chih S, Kobashigawa J, Madsen JC, Tellides G. Cardiac allograft vasculopathy: current review and future research directions. Cardiovasc Res. 2021 Nov 22;117(13):2624-2638. doi: 10.1093/cvr/cvab259. PMID 34343276
- Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Hark PMID 37080658
- Tavakol M, Ashraf S, Brener SJ. Risks and complications of coronary angiography: a comprehensive review. Glob J Health Sci. 2012 Jan 1;4(1):65-93. doi: 10.5539/gjhs.v4n1p65. PMID 22980117
- Sharma A, Cerdas MG, Reza-Soltani S, Rustagi V, Guntipalli M, Rojas Torres DS, Bhandari M, Kandel S, Teja Rayaprolu D, Hussain M. A Review of Photon-Counting Computed Tomography (PCCT) in the Diagnosis of Cardiovascular Diseases. Cureus. 2024 Nov 6;16(11):e73119. doi: 10.7759/cureus.73119. eCollection 2024 Nov. PMID 39650912
Identifiers
NCT: NCT07020039 · CAVIAR 2025