Anna Borowiec , Patrycja Ozdowska, Magdalena Rosinska, Agnieszka Jagiello-Gruszfeld, Slawomir Jasek ,Joanna Waniewska, Beata Kotowicz,Hanna Kosela-Paterczyk, Elzbieta Lampka,Agata Makowka,Małgorzata Fuksiewicz, Magdalena Chojnacka, Agnieszka Zebrowska, Katarzyna Gepner, Aleksandra Kapala, Andrzej Cieszanowski,Zbigniew Nowecki, Jan Walewski
Cardiological complications of oncological treatment, including the most serious one, heart failure, constitute a significant and still unsolved clinical problem. A history of dyslipidemia and complications of atherosclerosis, including coronary artery disease, are established risk factors for cardiotoxicity in cancer patients. In recent years, a protective effect of statin treatment on the development of heart failure in cancer patients has been observed. This protocol describes a study aiming to assess the prognostic value of coronary atherosclerosis burden and the CAC score on the onset of cardiac dysfunction associated with cancer therapy
Materials and Methods
The ANTEC Trial is a single-center, prospective, observational trial evaluating the impact of atherosclerosis in the coronary arteries determined by computed tomography on the risk of cardiotoxicity related to anthracycline-based chemotherapy. The trial is being carried out in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The conduct of the study is approved by an Independent Ethics Committee at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw (the date of approval– 28 October 2021, approval no. 80/2021) and all participants will provide written informed consent before study entry. The registration identifier on clinicaltrials.gov is NCT05118178.
In all patients, a single coronary computed tomographic angiography (CCTA) will be performed at the beginning of the study, with calculation of coronary artery calcium (CAC) score according to the Agatston method. Contrast cardiac CT scanning for CAC quantification will be performed with a 64-slice CT scanner (Revolution Evo, GE Healthcare, Waukesha, USA) with prospective ECG triggering. A tube voltage of 120kVp will be used. Images will be reconstructed with a slice thickness of 0.625 mm and CACS was quantified using the Agatston method with dedicated software by a well-trained researcher.
Recent studies suggest cardioprotective effect of statins on cardiotoxicity during oncological treatment [14–23]. Statins lower the cholesterol level, prevent atherosclerosis development and atherosclerosis complications . On this basis, the European Society of Cardiology 2022 guidelines recommend considering statins for primary prevention of cardiac dysfunction associated with cancer therapy in patients at high and very high cardiovascular toxicity risk . However, there are only a few prospective studies that have shown a positive effect of statins use in cardiotoxicity prevention [14, 22]
This is the first study to prospectively evaluate the influence of asymptomatic atherosclerosis in coronary arteries on chemotherapy-related cardiac dysfunction. This work may contribute to a better understanding of the pathophysiology of cardiotoxicity and to changing the standards of management and improving survival in oncological patients.
Citation: Borowiec A, Ozdowska P, Rosinska M, Jagiello-Gruszfeld A, Jasek S, Waniewska J, et al. (2023) Prognostic value of coronary atherosclerosis and CAC score for the risk of chemotherapy-related cardiac dysfunction (CTRCD): The protocol of ANTEC study. PLoS ONE 18(8): e0288146. https://doi.org/10.1371/journal.pone.0288146
Editor: Steven Shea, Columbia University Medical Center, UNITED STATES
Received: November 9, 2022; Accepted: June 20, 2023; Published: August 17, 2023
Copyright: © 2023 Borowiec et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: Deidentified research data will be made publicly available when the study is completed and published.
Funding: Anna Borowiec - supported by research grant from Polish Cardiac Society in cooperation with Servier. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.