Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Myocardial salvage measured by magnetic resonance imaging
研究概览
简要总结
Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced nephropathy in stable patients undergoing additional hydration.
In primary percutaneous intervention for infarction hydration is not possible. Therefore Acetylcystein might prevent contrast dye induced nephropathy.
Furthermore, it might reduce infarct size as a result of its antioxidant properties.
Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and infarct size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-elevation infarction (<12 hours)
排除标准
- •Prior fibrinolysis
- •Pregnancy
- •Lactase-reduction
- •Glucose-galactose malabsorption
- •Known allergy to acetylcystein
研究组 & 干预措施
1
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
干预措施: Acetylcystein (Drug)
2
Placebo (NaCl)
干预措施: Placebo (Drug)
结局指标
主要结局
Myocardial salvage measured by magnetic resonance imaging
时间窗: 4 days
prevention of nephropathy
时间窗: 3 days
次要结局
- TIMI flow(minutes)
- composite clinical endpoint (death, reinfarction, congestive heart failure)(30 days)
- ST-segment resolution(90 min)
- need for dialysis(4 days)
- oxidative stress(72 hours)
- microvascular obstruction measured by magnetic resonance(4 days)
- infarct size measured by magnetic resonance(4 days)