Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty of Heinrich Heine University, University Hospital Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
Department of Endocrinology and Diabetology, Medical Faculty of Heinrich Heine University, University Hospital Düsseldorf, Düsseldorf, Germany.
BMC Cardiovasc Disord. 2023 May 3;23(1):232. doi: 10.1186/s12872-023-03210-1.
ST-segment elevation myocardial infarction (STEMI) still causes significant mortality and morbidity despite best-practice revascularization and adjunct medical strategies. Within the STEMI population, there is a spectrum of higher and lower risk patients with respect to major adverse cardiovascular and cerebral events (MACCE) or re-hospitalization due to heart failure. Myocardial and systemic metabolic disorders modulate patient risk in STEMI. Systematic cardiocirculatory and metabolic phenotyping to assess the bidirectional interaction of cardiac and systemic metabolism in myocardial ischemia is lacking.
Systemic organ communication in STEMI (SYSTEMI) is an all-comer open-end prospective study in STEMI patients > 18 years of age to assess the interaction of cardiac and systemic metabolism in STEMI by systematically collecting data on a regional and systemic level. Primary endpoint will be myocardial function, left ventricular remodelling, myocardial texture and coronary patency at 6 month after STEMI. Secondary endpoint will be all-cause death, MACCE, and re-hospitalisation due to heart failure or revascularisation assessed 12 month after STEMI. The objective of SYSTEMI is to identify metabolic systemic and myocardial master switches that determine primary and secondary endpoints. In SYSTEMI 150-200 patients are expected to be recruited per year. Patient data will be collected at the index event, within 24 h, 5 days as well as 6 and 12 months after STEMI. Data acquisition will be performed in multilayer approaches. Myocardial function will be assessed by using serial cardiac imaging with cineventriculography, echocardiography and cardiovascular magnetic resonance. Myocardial metabolism will be analysed by multi-nuclei magnetic resonance spectroscopy. Systemic metabolism will be approached by serial liquid biopsies and analysed with respect to glucose and lipid metabolism as well as oxygen transport. In summary, SYSTEMI enables a comprehensive data analysis on the levels of organ structure and function alongside hemodynamic, genomic and transcriptomic information to assess cardiac and systemic metabolism.
SYSTEMI aims to identify novel metabolic patterns and master-switches in the interaction of cardiac and systemic metabolism to improve diagnostic and therapeutic algorithms in myocardial ischemia for patient-risk assessment and tailored therapy.
Trial Registration Number: NCT03539133.
尽管采用了最佳血运重建和辅助药物治疗策略,ST 段抬高型心肌梗死(STEMI)仍然导致了大量的死亡和发病。在 STEMI 人群中,存在一系列高危和低危患者,这些患者发生主要不良心血管和脑事件(MACCE)或心力衰竭再住院的风险不同。心肌和全身代谢紊乱调节 STEMI 患者的风险。系统的心脏循环和代谢表型分析评估心肌缺血中心脏和全身代谢的双向相互作用的方法尚未建立。
STEMI 中的系统性器官通讯(SYSTEMI)是一项面向所有患者的开放性前瞻性研究,纳入年龄>18 岁的 STEMI 患者,通过系统地在区域和全身水平上收集数据来评估 STEMI 中心脏和全身代谢的相互作用。主要终点为 STEMI 后 6 个月的心肌功能、左心室重构、心肌纹理和冠状动脉通畅性。次要终点为 STEMI 后 12 个月时全因死亡、MACCE 以及因心力衰竭或血运重建而再次住院。SYSTEMI 的目的是确定决定主要和次要终点的代谢系统和心肌主开关。预计每年将在 SYSTEMI 中招募 150-200 例患者。患者数据将在指数事件时、24 小时内、5 天以及 STEMI 后 6 个月和 12 个月时收集。数据采集将通过多层方法进行。心肌功能将通过连续的心脏成像进行评估,包括电影心室造影、超声心动图和心血管磁共振。心肌代谢将通过多核磁共振波谱进行分析。系统代谢将通过连续的液体活检并分析葡萄糖和脂质代谢以及氧输送来进行评估。总之,SYSTEMI 能够在器官结构和功能水平上进行全面数据分析,以及血液动力学、基因组和转录组信息,以评估心脏和全身代谢。
SYSTEMI 旨在确定心脏和全身代谢相互作用中的新型代谢模式和主开关,以改善心肌缺血的诊断和治疗算法,用于患者风险评估和靶向治疗。
试验注册号:NCT03539133。