BACKGROUND Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H2S) reduces "ischemia-reperfusion injury" in various experimental animal models, but has not been evaluated in humans. This trial will examine the efficacy and safety of the H2S-donor sodium thiosulfate (STS) in patients presenting with a STEMI. STUDY DESIGN The Groningen Intervention study for the Preservation of cardiac function with STS after STEMI (GIPS-IV) trial (NCT02899364) is a double-blind, randomized, placebo-controlled, multicenter trial, which will enroll 380 patients with a first STEMI. Patients receive STS 12.5 grams intravenously or matching placebo in addition to standard care immediately at arrival at the catheterization laboratory after providing consent. A second dose is administered 6 hours later at the coronary care unit. The primary endpoint is myocardial infarct size as quantified by cardiac magnetic resonance imaging 4 months after randomization. Secondary endpoints include the effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels at 4 months follow-up. Patients will be followed-up for 2 years to assess clinical endpoints. CONCLUSIONS The GIPS-IV trial is the first study to determine the effect of a H2S-donor on myocardial infarct size in patients presenting with STEMI.

中文翻译：

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St 段抬高型心肌梗死 (GIPS-IV) 试验后用硫代硫酸钠保护心脏功能的格罗宁根干预研究的原理和设计。

背景缺血和随后的再灌注会导致 ST 段抬高型心肌梗死 (STEMI) 患者出现心肌损伤。硫化氢 (H2S) 可减少各种实验动物模型中的“缺血再灌注损伤”，但尚未在人体中进行评估。该试验将检查 H2S 供体硫代硫酸钠 (STS) 在 STEMI 患者中的疗效和安全性。研究设计 STEMI (GIPS-IV) 试验 (NCT02899364) 是一项双盲、随机、安慰剂对照、多中心试验，将招募 380 名首次 STEMI 患者。患者接受 STS 12。在提供同意后立即在到达导管实验室时，除了标准护理外，静脉注射 5 克或匹配安慰剂。6 小时后在冠状动脉监护病房给予第二剂。主要终点是随机化后 4 个月通过心脏磁共振成像量化的心肌梗死面积。次要终点包括 STS 对入院时 CK-MB 峰值和 4 个月随访时左心室射血分数和 NT-proBNP 水平的影响。患者将被随访 2 年以评估临床终点。结论 GIPS-IV 试验是第一项确定 H2S 供体对 STEMI 患者心肌梗死面积影响的研究。主要终点是随机化后 4 个月通过心脏磁共振成像量化的心肌梗死面积。次要终点包括 STS 对入院时 CK-MB 峰值和 4 个月随访时左心室射血分数和 NT-proBNP 水平的影响。患者将被随访 2 年以评估临床终点。结论 GIPS-IV 试验是第一项确定 H2S 供体对 STEMI 患者心肌梗死面积影响的研究。主要终点是随机化后 4 个月通过心脏磁共振成像量化的心肌梗死面积。次要终点包括 STS 对入院时 CK-MB 峰值和 4 个月随访时左心室射血分数和 NT-proBNP 水平的影响。患者将被随访 2 年以评估临床终点。结论 GIPS-IV 试验是第一项确定 H2S 供体对 STEMI 患者心肌梗死面积影响的研究。