Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- acute kidney injury
研究概览
简要总结
This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.
详细描述
Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes undergoing percutaneous coronary intervention were included.
排除标准
- •emergency PCI,
- •baseline troponin value > 0.04 ng/mL,
- •nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
- •patient on dialysis,
- •patients who had some inability to cooperate with the trial,
- •those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
结局指标
主要结局
acute kidney injury
时间窗: 72 hours after procedure
The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used).
次要结局
- relative reduction in estimated glomerular filtration rate(180 days after procedure)
研究者
Yujie Zhou
professor of cardiology, Vice president of Beijing Anzhen Hospital
Beijing Anzhen Hospital