Background:

Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is a significant cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for novel effective treatments. Evidence suggests that delivery of nitric oxide (NO) through chemical reduction of inorganic nitrate to NO may offer a novel therapeutic strategy to reduce CIN and thus preserve long term renal function.

Design:

The NITRATE-CIN trial is a single-center, randomized, double-blind placebo-controlled trial, which plans to recruit 640 patients presenting with acute coronary syndromes (ACS) who are at risk of CIN. Patients will be randomized to either inorganic nitrate therapy (capsules containing 12 mmol KNO₃) or placebo capsules containing potassium chloride (KCl) daily for 5 days. The primary endpoint is development of CIN using the Kidney Disease Improving Global Outcomes (KDIGO) criteria. A key secondary endpoint is renal function over a 3-month follow-up period. Additional secondary endpoints include serum renal biomarkers (e.g. neutrophil gelatinase-associated lipocalin) at 6 h, 48 h and 3 months following administration of contrast. Cost-effectiveness of inorganic nitrate therapy will also be evaluated.

Summary:

This study is designed to investigate the hypothesis that inorganic nitrate treatment decreases the rate of CIN as part of semi-emergent coronary angiography for ACS. Inorganic nitrate is a simple and easy to administer intervention that may prove useful in prevention of CIN in at-risk patients undergoing coronary angiographic procedures.

中文翻译：

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NITRATE-CIN 研究：一项随机 (1:1) 英国单中心双盲安慰剂对照试验的方案，测试无机硝酸盐对急性冠状动脉综合征冠状动脉造影患者对比剂肾病的影响

背景：

造影剂肾病 (CIN) 是一种由血管内含碘造影剂引起的急性肾损伤，是高危患者冠状动脉造影手术后发病率/死亡率的重要原因。尽管采取了旨在降低 CIN 风险的预防措施，但仍然需要新的有效治疗方法。有证据表明，通过将无机硝酸盐化学还原为 NO 来递送一氧化氮 (NO) 可能会提供一种新的治疗策略来减少 CIN，从而保持长期肾功能。

设计：

NITRATE-CIN 试验是一项单中心、随机、双盲安慰剂对照试验，计划招募 640 名有 CIN 风险的急性冠状动脉综合征 (ACS) 患者。患者将每天随机接受无机硝酸盐治疗（含有 12 mmol KNO ₃的胶囊）或含有氯化钾 (KCl) 的安慰剂胶囊，持续 5 天。主要终点是使用肾脏疾病改善全球结果 (KDIGO) 标准开发 CIN。一个关键的次要终点是 3 个月随访期间的肾功能。其他次要终点包括对比剂给药后 6 小时、48 小时和 3 个月的血清肾脏生物标志物（例如中性粒细胞明胶酶相关的脂质运载蛋白）。还将评估无机硝酸盐疗法的成本效益。

概括：

本研究旨在调查无机硝酸盐治疗降低 CIN 发生率的假设，这是 ACS 半急诊冠状动脉造影的一部分。无机硝酸盐是一种简单且易于管理的干预措施，可能证明对预防接受冠状动脉造影手术的高危患者的 CIN 有用。