冠状动脉粥样硬化和 CAC 评分对化疗相关心脏功能障碍（CTRCD）风险的预后价值：ANTEC 研究方案。
Prognostic value of coronary atherosclerosis and CAC score for the risk of chemotherapy-related cardiac dysfunction (CTRCD): The protocol of ANTEC study.
机构信息
Department of Cancer & Cardio-Oncology Diagnostics, The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Department of Computational Oncology, The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
出版信息
PLoS One. 2023 Aug 17;18(8):e0288146. doi: 10.1371/journal.pone.0288146. eCollection 2023.
BACKGROUND
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.
METHODS
ANTEC (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 REGISTRY
This study is listed on cinicaltrials.gov with identifier NCT05118178.
背景
肿瘤治疗相关的心脏并发症，包括最严重的心力衰竭，是一个重要且尚未解决的临床问题。血脂异常病史和动脉粥样硬化并发症，包括冠心病，是癌症患者发生心脏毒性的既定危险因素。近年来，观察到他汀类药物治疗对癌症患者心力衰竭发展的保护作用。本方案描述了一项旨在评估冠状动脉粥样硬化负担和 CAC 评分对与癌症治疗相关的心脏功能障碍发生的预测价值的研究。
方法
ANTEC（化疗相关心脏毒性的动脉粥样硬化）是一项单中心、前瞻性、观察性研究，旨在评估通过计算机断层扫描评估的冠状动脉粥样硬化和 CAC 评分对接受高剂量蒽环类药物化疗（阿霉素≥240mg/m2 体质量或表阿霉素≥600mg/m2 体质量）的癌症患者发生左心室收缩功能障碍的影响，这些患者至少具有中度心脏毒性风险。将纳入 80 例在接受高剂量蒽环类药物化疗（阿霉素≥240mg/m2 体质量或表阿霉素≥600mg/m2 体质量）之前诊断为癌症且无心力衰竭和冠心病病史的患者。计划对所有患者进行 12 个月的随访。所有患者将在研究开始时进行一次冠状动脉计算机断层血管造影术（CCTA）。主要终点是癌症治疗相关心血管毒性的发生，根据 ESC 2022 年心血管肿瘤学指南定义为轻度、中度、重度和极重度。在随访期间，每三个月进行一次超声心动图评估左心室整体纵向应变（GLS）。此外，每 6 个月测量一次新的动脉粥样硬化生物标志物（IL-6、MPO、TNF-α）。该研究在 clinicaltrials.gov 的注册号为 NCT05118178。
临床试验注册
该研究在 clinicaltrials.gov 上注册，注册号为 NCT05118178。
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