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临床试验/NCT07020039
NCT07020039尚未招募不适用

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

Sahlgrenska University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic accuracy of PCCT compared to ICA in detecting CAV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult heart transplant recipients.
  • Clinically stable and scheduled for routine ICA.
  • Ability to provide informed consent

排除标准

  • 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.

结局指标

主要结局

Diagnostic accuracy of PCCT compared to ICA in detecting CAV

时间窗: 2 days

Non-invasive investigation compared to invasive procedures

Level of agreement between PCCT and ICA in grading CAV severity

时间窗: 2 days

Non-invasive investigation compared with invasive procedures

次要结局

  • Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.(2 days)
  • Radiation dose exposure using PCCT contra ICA/IVUS.(2 days)
  • Cost-effectiveness of PCCT versus ICA/IVUS(2 days)
  • Patient comfort and procedural time differences with PCCT versus IVA/IVUS(2 days)

研究者

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristjan Karason

MD, PhD

Sahlgrenska University Hospital

研究点 (1)

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