Clinical trial NCT07020039: Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
Official title: Comparing Photon Counting Computed Tomography With Invasive Coronary Angiography and Intravascular Ultrasound in Detecting Cardiac Allograft Vasculopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Allograft Vasculopathy
Keywords: Heart transplantation
Cardiac allograft vasculopathy
photon counting computed tomography
Invasive coronary angiography
Intravascular ultrasound
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2025-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult heart transplant recipients scheduled for routine coronary angiography

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.

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.

Primary outcomes:
measure: Diagnostic accuracy of PCCT compared to ICA in detecting CAV
timeFrame: 2 days
measure: Level of agreement between PCCT and ICA in grading CAV severity
timeFrame: 2 days
Secondary outcomes:
measure: Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.
timeFrame: 2 days
measure: Radiation dose exposure using PCCT contra ICA/IVUS.
timeFrame: 2 days
measure: Cost-effectiveness of PCCT versus ICA/IVUS
timeFrame: 2 days
measure: Patient comfort and procedural time differences with PCCT versus IVA/IVUS
timeFrame: 2 days
Other outcomes:
measure: Relationship between CAV and periarterial fat density as well as myocardial fibrosis
timeFrame: 1 day
Locations:
city: Gothenburg
country: Sweden
facility: Transplant Institute
state: Vastra Gotaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Kristjan Karason, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.
citation: 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.
citation: 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.