对接受全弓置换术的急性 A 型主动脉夹层患者使用甲基强的松龙：Medal 试验的设计与原理：简短标题 Medal试验的研究方案。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-10-11 DOI:10.1016/j.ahj.2024.10.003

Shujie Yan MD, PhD , Fuqing Jiang MD , Yanhua Sun MD , Yang Wang PhD , Jianxi Ye MD, PhD , Jianchao Li MD , Hui Yang MD , Shifu Wang MD , Yi Song MD , Chengbin Zhou MD, PhD , Bingyang Ji MD, PhD

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引用次数: 0

摘要

背景：急性 A 型主动脉夹层（ATAAD）急诊全主动脉弓置换术（TAAR）的死亡率和发病率很高，部分原因是过度激活的全身炎症反应。甲基强的松龙是一种抗炎药物，可抑制全身炎症反应，从而改善预后。然而，甲基强的松龙对 ATAAD TAAR 的保护作用尚未明确。方法和结果：Medal 试验是一项前瞻性、多中心、随机、双盲、安慰剂对照、平行组试验，旨在评估与安慰剂相比，在心肺旁路术前静脉注射 500 mg 甲基强的松龙是否能降低术后主要器官损伤的发生率。被诊断为 ATAAD 的成人患者将被纳入该试验，他们正在等待通过低体温循环停滞和选择性脑灌注进行急诊全主动脉弓置换术。来自九个大型心血管中心的 340 名合格受试者将按 1:1 的比例随机分配，在心肺旁路术前接受 500 毫克甲基强的松龙或安慰剂治疗。主要结果是术后主要不良反应[定义为全因死亡或术后神经功能缺损或 KDIGO II -III 急性肾损伤或呼吸综合征（气管插管> 72 小时、气管切开或再次插管），直至术后第 30 天或患者出院]。该研究已获得九个参与中心当地伦理委员会的批准，并于 2022 年 6 月 24 日招募了第一名受试者。截至 2024 年 9 月 5 日，已有 323 名受试者入组。Medal试验的结果将在数据收集和分析完成后公布：Medal试验将确定500毫克甲基强的松龙对接受TAAR治疗的ATAAD患者的疗效：URL https://www.chictr.org.cn/searchprojEN.html（中国临床试验注册中心）。唯一标识符：ChiCTR2200059286。

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Methylprednisolone for acute type A aortic dissection patients undergoing total arch replacement: Design and rationale of the Medal trial

Background

The mortality and morbidity of emergency total aortic arch replacement (TAAR) for acute type A aortic dissection (ATAAD) is high, which is partly due to the excessively activated systemic inflammatory response. Methylprednisolone, an anti-inflammatory agent, might suppress the systemic inflammatory response and lead to improved outcomes. However, the protective effects of methylprednisolone on TAAR for ATAAD were not clarified. The usage and dosage varied in different centers across the world.

Methods and results

The Medal trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate whether 500 mg methylprednisolone IV before cardiopulmonary bypass could reduce the incidence of postoperative major organ injury, compared to placebo. Adult patients with the diagnosis with ATAAD, awaiting emergency total aortic arch replacement with hypothermic circulatory arrest and selective cerebral perfusion will be included in the trial. A total of 340 eligible subjects from 9 large cardiovascular centers will be randomized in a 1:1 ratio to receive 500 mg methylprednislone or placebo before cardiopulmonary bypass. The primary outcome is postoperative major adverse outcome [defined as all-cause death or postoperative neurological deficit or KDIGO II -III acute kidney injury or respiratory syndrome (tracheal intubation> 72 hours, tracheostomy or re-intubation) until postoperative day 30 or patient discharge]. The study has received approval from the local Ethics Committees of the 9 participating centers, and enrolled its first subject in June 24, 2022. As of September 5, 2024, 323 subjects have been enrolled. Results of the Medal trial will be published once data collection and analysis have been completed.

Conclusions

The Medal trial will determine the effectiveness of 500 mg methylprednisolone on the outcomes of patients with ATAAD undergoing TAAR.

Registration

URL https://www.chictr.org.cn/searchprojEN.html (Chinese Clinical Trial Registry). Unique identifier: ChiCTR2200059286

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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.