Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Increase in serum creatinin level (≥25% or 0,5mg/dL)
研究概览
简要总结
This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.
详细描述
Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.
Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.
We will evaluate the effect of remote preconditioning on renal protection.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient headed to coronary angiography
- •Glomerular filtration rate :
- •≤ 40ml/min/1,73m² (MDRD equation)
- •or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA ≥ III/IV, diabetes mellitus
- •Signed informed consent
排除标准
- •Preoperative assessment / dilated cardiomyopathy assessment
- •Acute ST-segment elevation myocardial infarction
- •Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg
- •Resuscitation after cardiac arrest
- •Intra-aortic balloon pump
- •Contraindication for the repeted use of an upper-arm pressure cuff
- •Extra-renal epuration
- •No health insurance coverage
- •Legal incapacity (patients under tutorship, curatorship or judicial protection)
- •Patient enrolled in another interventional trial or being in a washout period
- •Incapacity/impossibility to undergo 12-month follow-up
- •Patient refusal
研究组 & 干预措施
Remote Ischemic Preconditioning
A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.
The procedure has to be completed between 5 and 60 minutes prior coronary angiography.
干预措施: Coronary Angiography (Procedure)
Control
A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.
The procedure has to be completed between 5 and 60 minutes prior coronary angiography.
干预措施: Coronary Angiography (Procedure)
结局指标
主要结局
Increase in serum creatinin level (≥25% or 0,5mg/dL)
时间窗: 48h after coronary angiography
Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy
次要结局
- Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function(12 months after coronary angiography)