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临床试验/NCT00237614
NCT00237614已完成2 期

Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

University of Milan2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
300
试验地点
2
主要终点
Incidence of contrast-induced nephropathy

研究概览

简要总结

Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients admitted to the Coronary Care Unit for ST-segment elevation acute myocardial infarction undergoing primary angioplasty. Patients were included if they presented within 12 hours (18 hours for acute myocardial infarction complicated by cardiogenic shock) from the onset of symptoms. -

排除标准

  • Patients in chronic peritoneal or hemodialytic treatment and those with known allergy to N-acetylcysteine.

结局指标

主要结局

Incidence of contrast-induced nephropathy

次要结局

  • In-hospital major clinical adverse events including death

研究者

申办方类型
Other

研究点 (2)

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