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NCT Number: NCT07020039

Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Transplant Institute

Gothenburg, Västra Götaland County, 41345, Sweden

Location contact

Entela Bollano, MD, PhD

SUB_INVESTIGATOR

Erika Fagman, MD, PhD

SUB_INVESTIGATOR

Gustav Smith, Professor

SUB_INVESTIGATOR

Kristjan Karason, MD, PhD

PRINCIPAL_INVESTIGATOR

Markus Gabel, MD

CONTACT

[email protected]

+46 31 3421000

Niclas Kvarnström, MD, PhD

CONTACT

[email protected]

+46 31 3421000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of PCCT compared to ICA in detecting CAV

    Time frame: 2 days

    Non-invasive investigation compared to invasive procedures

  2. Level of agreement between PCCT and ICA in grading CAV severity

    Time frame: 2 days

    Non-invasive investigation compared with invasive procedures

Secondary outcomes

  1. Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.

    Time frame: 2 days

    PCCT compared with IVUS

  2. Radiation dose exposure using PCCT contra ICA/IVUS.

    Time frame: 2 days

    Radiation dose compared between PCCT and ICA/IVUS

  3. Cost-effectiveness of PCCT versus ICA/IVUS

    Time frame: 2 days

    The cost of PCCT verus ICA/IVUS

  4. Patient comfort and procedural time differences with PCCT versus IVA/IVUS

    Time frame: 2 days

    Comparing patient comfort during PCCT and ICA/IVUS, respectively

Other outcomes

  1. Relationship between CAV and periarterial fat density as well as myocardial fibrosis

    Time frame: 1 day

    To see whether periarterial fat density and myocardial fibrosis are related to CAV

Study contacts

Contact information is provided by the study sponsor or research team.

Entela Bollano, MD, PhD

CONTACT

[email protected]

+46 70 7910635

Kristjan Karason, MD, PhD

CONTACT

[email protected]

+46 739401560

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: CAVIAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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