Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-07-28 DOI:10.1016/j.ahj.2025.07.067

Sebastian J. Reinstadler MD, PhD , Andreas Kronbichler MD, PhD , Martin Reindl MD, PhD , Christina Tiller MD, PhD , Magdalena Holzknecht MD, PhD , Fritz Oberhollenzer MD , Alex Kaser MD , Philipp Gauckler MD , Thomas Stiermaier MD , Hans-Josef Feistritzer MD, PhD , Agnes Mayr MD , Elke R. Gizewski MD, MHBA , Richard Rezar MD, PhD , Heiko Bugger MD , Kathrin Eller MD , Ingo Eitel MD , Steffen Schneider PhD , Gert Mayer MD , Holger Thiele MD , Axel Bauer MD , Ivan Lechner MD, PhD

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引用次数: 0

Abstract

Background

Despite the effectiveness of primary percutaneous coronary intervention (PCI) in treating ST-elevation myocardial infarction (STEMI), myocardial salvage is often incomplete, resulting in large infarct size and an increased risk of heart failure and mortality. Inflammation is involved in this process, with C-reactive protein (CRP) potentially contributing to infarct expansion. Whether selective CRP apheresis in addition to standard care can reduce infarct size in STEMI remains to be determined.

Trial Design

Selective C-reactive protein apheresis in ST-elevation myocardial infarction (CRP-STEMI) is an investigator-initiated, randomized, open-label (outcome assessor blinded), multicenter trial investigating whether selective CRP apheresis using the PentraSorb-CRP system, in addition to standard care, can reduce infarct size in STEMI patients undergoing PCI within 12 hours of symptom onset. The trial will enroll 202 patients at 5 tertiary care centers in Austria and Germany, randomized 1:1 to either the intervention group (standard care + CRP apheresis) or the control group (standard care). In the intervention group, CRP apheresis will be performed on days 1, 2, and 3 post-PCI. The primary endpoint is infarct size as assessed by late gadolinium enhanced cardiac magnetic resonance at 5 ± 2 days after PCI.

Outlook

CRP-STEMI is the first randomized trial to investigate whether selective CRP apheresis, as an adjunct to standard care, can effectively reduce infarct size in acute STEMI patients.

Trial Registration

CRP-STEMI, NCT04939805, is registered at https://clinicaltrials.gov/study/NCT04939805.

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选择性c反应蛋白分离治疗st段抬高型心肌梗死：随机CRP-STEMI试验的设计和基本原理

背景：尽管初级经皮冠状动脉介入治疗（PCI）在治疗st段抬高型心肌梗死（STEMI）方面是有效的，但心肌抢救往往是不完整的，导致梗死面积大，心衰和死亡率的风险增加。炎症参与了这一过程，c反应蛋白（CRP）可能导致梗死扩大。在标准治疗的基础上，选择性CRP分离是否能减少STEMI患者的梗死面积仍有待确定。试验设计：选择性c反应蛋白分离治疗st段抬高型心肌梗死（CRP-STEMI）是一项研究者发起的、随机、开放标签（结果评估者盲法）、多中心试验，研究在标准治疗的基础上，使用PentraSorb®-CRP系统进行选择性CRP分离是否可以减少症状出现后12小时内接受PCI治疗的STEMI患者的梗死面积。该试验将在奥地利和德国的五个三级护理中心招募202名患者，以1:1的比例随机分配到干预组（标准治疗 + CRP分离）或对照组（标准治疗）。干预组在pci术后1、2、3天进行CRP采集。主要终点是在PCI术后5±2天通过晚期钆增强心脏磁共振评估梗死面积。展望：CRP-STEMI是首个随机试验，旨在研究选择性CRP分离作为标准治疗的辅助手段是否能有效减少急性STEMI患者的梗死面积。试验注册：CRP-STEMI， NCT04939805，注册网址：https://clinicaltrials.gov/study/ NCT04939805。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.