Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4.
Contrast-induced acute kidney injury (CI-AKI) is a complex syndrome of acute renal failure occurring after the administration of contrast media and contributing to prolonged hospital stay and mortality. The risk of CI-AKI is higher among patients undergoing primary percutaneous coronary interventions for acute myocardial infarction (AMI), but its clinical relevance in such setting has only been evaluated by small sample size single-center studies and retrospective or observational analyses. Furthermore, whereas high-osmolar contrast media was shown to have direct nephrotoxicity, the role of low-osmolar and iso-osmolar agents is still debated.
The CONTRAST-AMI study is a prospective, multicenter, controlled, randomized, single-blind, parallel-group trial, designed to show the noninferiority of the effects of iopromide (low-osmolar) compared with iodixanol (iso-osmolar) contrast media on the incidence of CI-AKI and tissue-level perfusion in patients with AMI. All consecutive patients admitted to participating centers for ST-segment elevation AMI undergoing primary percutaneous coronary intervention will be enrolled. All patients will be treated with high-dose N-acetylcysteine (1200 mg intravenously during the procedure and 1200 mg orally two times daily for the next 48 h after percutaneous coronary intervention) and hydration according to a standardized protocol. The primary endpoint is the proportion of patients with a relative increase in serum creatinine (sCr) of at least 25% from baseline to 72 h after agent administration. The secondary endpoints are absolute and relative increases in sCr of at least 50%, thrombolysis in myocardial infarction (TIMI) perfusion grade, and major adverse cardiac events at 1, 6, and 12 months.
The CONTRAST-AMI study will provide information on the effects of iodixanol and iopromide on the incidence of CI-AKI and tissue-level perfusion in patients with AMI.
对比剂诱导的急性肾损伤（CI-AKI）是一种在使用对比剂后发生的急性肾衰竭的复杂综合征，会导致住院时间延长和死亡率增加。在接受急性心肌梗死（AMI）的直接经皮冠状动脉介入治疗的患者中，CI-AKI 的风险更高，但在这种情况下，其临床相关性仅通过小样本量的单中心研究和回顾性或观察性分析进行了评估。此外，高渗对比剂被证明具有直接的肾毒性，而低渗和等渗对比剂的作用仍存在争议。
CONTRAST-AMI 研究是一项前瞻性、多中心、对照、随机、单盲、平行组试验，旨在证明碘普罗胺（低渗）与碘克沙醇（等渗）对比剂在 AMI 患者中对 CI-AKI 和组织水平灌注的影响无差异。所有连续因 ST 段抬高型 AMI 入住参与中心并接受直接经皮冠状动脉介入治疗的患者都将被纳入。所有患者将按照标准化方案接受大剂量 N-乙酰半胱氨酸（在手术期间静脉注射 1200 mg，经皮冠状动脉介入治疗后 48 h 内口服 1200 mg，每日两次）和水化治疗。主要终点是从基线到药物给药后 72 h 时血清肌酐（sCr）相对增加至少 25%的患者比例。次要终点是 sCr 的绝对和相对增加至少 50%、心肌梗死溶栓治疗（TIMI）灌注分级和 1、6 和 12 个月时的主要不良心脏事件。
CONTRAST-AMI 研究将提供关于碘克沙醇和碘普罗胺对 AMI 患者 CI-AKI 和组织水平灌注发生率的影响的信息。
