The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,110
- 试验地点
- 9
- 主要终点
- Incidence of acute kidney injury
研究概览
简要总结
The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.
详细描述
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.
Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing PCI with stenting for all clinical indications
- •carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù
- •younger than 85 years old.
排除标准
- •ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;
结局指标
主要结局
Incidence of acute kidney injury
时间窗: 24 and 48 hours after PCI
Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration
次要结局
- Incidence of periprocedural myocardial infarction(24 and 48 hours after PCI)
研究者
Claudio Moretti
Dottor, Head of the Catch Lab
A.O.U. Città della Salute e della Scienza