Jan Torzewski, Stephan Mattecka, Benjamin Mayer, Gregg W Stone, Ahmed Sheriff
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引用次数: 0
摘要
背景:长期以来,C反应蛋白(CRP)一直被认为是改善急性心肌梗死(AMI)预后的潜在治疗靶点。最近,在 COVID-19、急性 ST 段抬高型心肌梗死、心源性休克和非 ST 段抬高型急性冠状动脉综合征患者中,CRP 清除疗法已在首次人类病例报告、登记和试点试验中显示出良好的效果:在此,我们描述了一项关键性国际随机对照试验的前景,该试验旨在研究急性心肌梗死中的 CRP 清除疗法。我们在此提出了这项研究的原理、设计、终点和统计方法:我们的目标是证明 CRP 清除术治疗急性心肌梗死的安全性和有效性,降低心血管死亡率或心衰再住院率这一主要临床终点。
Selective C-reactive protein apheresis in acute myocardial infarction: rationale and design of a prospective international randomized controlled trial.
Background: C-reactive protein (CRP) has long been identified as a potential therapeutic target to improve outcomes in acute myocardial infarction (AMI). Recently, CRP apheresis has shown promising results from first-in-human case reports, registries, and pilot trials in patients with COVID-19, acute ST-segment elevation myocardial infarction, cardiogenic shock, and non-ST-segment elevation acute coronary syndromes.
Methods and results: Herein we describe the perspective for a pivotal, international, randomized controlled trial investigating CRP apheresis in AMI. We herein propose the rationale, design, endpoints, and statistical methodology of this study.
Conclusion: The goal is to demonstrate the safety and efficacy of CRP apheresis in AMI in reducing the combined primary clinical endpoint of cardiovascular mortality or rehospitalization for heart failure.
期刊介绍:
Coronary Artery Disease welcomes reports of original research with a clinical emphasis, including observational studies, clinical trials, translational research, novel imaging, pharmacology and interventional approaches as well as advances in laboratory research that contribute to the understanding of coronary artery disease. Each issue of Coronary Artery Disease is divided into four areas of focus: Original Research articles, Review in Depth articles by leading experts in the field, Editorials and Images in Coronary Artery Disease. The Editorials will comment on selected original research published in each issue of Coronary Artery Disease, as well as highlight controversies in coronary artery disease understanding and management.
Submitted artcles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.