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BackgroundCardiological 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.MethodsANTEC (Atherosclerosis iN chemoTherapy-rElated Cardiotoxicity) is a single-site, prospective, observational study to evaluate the influence of the coronary atherosclerosis and CAC score assessed by computed tomography on the development of left ventricular systolic dysfunction in cancer patients with at least moderate cardiotoxicity risk. A group of 80 patients diagnosed with cancer prior to high-dose anthracycline chemotherapy (doxorubicin ≥ 240 mg / m2 body weight or epirubicin ≥ 600 mg / m2 body weight), without a history of heart failure and coronary artery disease, will be included in the study. Patient follow-up is planned for 12 months. In all patients, coronary computed tomographic angiography (CCTA) will be performed once at the beginning of the study. The primary endpoint is the onset of cancer therapy-related cardiovascular toxicity, defined as mild, moderate, severe and very severe according to ESC 2022 Cardio-oncology guidelines. During follow up, echocardiography with GLS assessment will be performed every three months. Additionally, new biomarkers of atherosclerosis (IL-6, MPO, TNF-alpha) will be measured every 6 months. The study registration identifier on clinicaltrials.gov is NCT05118178.Clinical trials registryThis study is listed on cinicaltrials.gov with identifier NCT05118178.研究背景 肿瘤治疗相关心血管并发症（其中最为严重的类型为心力衰竭）是当前尚未得到有效解决的重大临床难题。血脂异常病史以及动脉粥样硬化相关并发症（包括冠状动脉粥样硬化性心脏病）已被证实为肿瘤患者发生心脏毒性的明确危险因素。近年来有研究发现，他汀类药物治疗可对肿瘤患者心力衰竭的发生起到保护作用。本研究方案旨在评估冠状动脉粥样硬化负荷以及冠状动脉钙化评分（CAC score）对肿瘤治疗相关心功能障碍发生的预测价值。 研究方法 本研究为单中心前瞻性观察性研究，命名为ANTEC（化疗相关心脏毒性中的动脉粥样硬化研究，Atherosclerosis iN chemoTherapy-rElated Cardiotoxicity），旨在评估通过计算机断层扫描（CT）评估的冠状动脉粥样硬化情况与冠状动脉钙化评分（CAC score），对存在至少中度心脏毒性风险的肿瘤患者发生左心室收缩功能障碍的影响。本研究将纳入80例符合以下条件的患者：在接受高剂量蒽环类化疗前已确诊癌症（阿霉素剂量≥240mg/体表面积平方米，或表柔比星剂量≥600mg/体表面积平方米），且无心力衰竭与冠状动脉粥样硬化性心脏病病史。患者随访周期设定为12个月。所有患者将在研究初始阶段完成一次冠状动脉计算机断层血管造影（CCTA）检查。本研究的主要终点为肿瘤治疗相关心血管毒性的发生，该毒性依据《2022年欧洲心脏病学会（ESC）肿瘤心脏病学指南》分为轻度、中度、重度与极重度四个等级。随访期间，每3个月将为患者完成一次包含整体纵向应变（GLS）评估的超声心动图检查。此外，每6个月将检测一次动脉粥样硬化新型生物标志物：白细胞介素6（IL-6）、髓过氧化物酶（MPO）与肿瘤坏死因子α（TNF-α）。本研究在ClinicalTrials.gov的注册编号为NCT05118178。 临床试验注册信息 本研究已在ClinicalTrials.gov完成注册，注册编号为NCT05118178。