桡动脉通道过饱和氧治疗预防st段抬高型心肌梗死后左室重构：一项随机对照试验

IF 1.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal plus : cardiology research and practice Pub Date : 2025-05-28 DOI:10.1016/j.ahjo.2025.100556

Francis R. Joshi , Maria Petty , Yen Wing Ng , Hamish Elliott , Ross Anderson , Douglas Gordon , Rebecca Hanna , Robert Sykes , Shaun Leonard , Andrew Morrow , Dylan Tan , Anna Kamdar , Ramu Perumal , Jeffrey L. Creech , Peter Kellman , Paul Welsh , Alex McConnachie , Colin Berry

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引用次数: 0

摘要

背景：目前缺乏新的策略来限制梗死的大小，防止急性st段抬高型心肌梗死（STEMI）患者的不良重构和心力衰竭。过饱和氧（SSO2）治疗被批准用于在STEMI前路发病6小时内通过股动脉通路的患者。通过放射状通路进行SSO2治疗的可行性尚不清楚。需要对治疗效果有更详细的了解。目的评估主要结局，定义为在心肌梗死后基线、24小时、2-5天和3个月时测量的NT-proBNP血浆浓度的参与者内变化。前瞻性、随机、对照、盲法、终点（机制、探针）临床试验。随机对照试验：首次PCI后，符合条件的参与者将进行盲法和2:1随机分组，接受1小时的SSO2治疗，使用桡动脉通路和静脉注射糖蛋白IIbIIIa抑制剂治疗，或在标准治疗的基础上进行对照（假）操作。主要结局是参与者体内NT-proBNP血浆浓度的变化，如上所述。次要结局评估包括冠状动脉微循环功能、梗死面积、微血管阻塞、心肌出血、左心室重构、心肌血流量、生活质量（EQ-5D-5L）、堪萨斯城心肌病问卷（KCCQ）和杜克活动状态指数。患者报告经验测量（PREMS）是一种探索性结果。将使用电子医疗记录评估健康和经济成果。该研究将测试桡动脉通路的可行性，提供机制数据，并为更大的多中心试验提供信息，以检测治疗对临床终点的影响

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Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial

Background

Novel strategies to limit the size of infarction and prevent adverse remodeling and heart failure in patients following acute ST-segment elevation myocardial infarction (STEMI) are lacking. Supersaturated oxygen (SSO₂) therapy is approved for patients presenting within 6 h of onset of anterior STEMI using femoral artery access. The feasibility of SSO₂ therapy via radial access is unknown. A more detailed understanding of the effect of therapy is needed.

Objectives

To assess the primary outcome, defined as the within-participant change in the plasma concentration of NT-proBNP measured at baseline, 24 h, 2–5 days and 3-months post-MI.

Design

Prospective, randomized, controlled, blinded, endpoint (mechanistic, PROBE) clinical trial.

Randomized, controlled trial

After primary PCI, eligible participants will be blinded and randomized 2:1 to either 1 h of SSO₂ therapy using radial artery access and intravenous glycoprotein IIbIIIa inhibitor therapy or a control (sham) procedure involving wrist manipulation in addition to standard care. The primary outcome is the within-participant change in the plasma concentration of NT-proBNP as detailed above. Secondary outcome assessments include coronary microcirculatory function, infarct size, microvascular obstruction, myocardial hemorrhage, left ventricular remodeling, myocardial blood flow, quality of life (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Duke Activity Status Index. Patient reported experience measures (PREMS) are an exploratory outcome. Health and economic outcomes will be assessed using electronic healthcare records.

Value

The study will test the feasibility of radial artery access, provide mechanistic data and inform a larger multicenter trial powered to detect treatment effects on clinical endpoints.

Clinicaltrials.gov: NCT06662890

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