REduction of rIsk for Contrast-Induced Nephropathy (REICIN) Study:RESCIND-P (Prospective Observational Study for REduction of contraSt-induced Nephropathy and Cardiaovascular Events followINg carDiac Catheterization)
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 12
- 主要终点
- contrast-induced nephropathy
研究概览
简要总结
The REduction of rIsk for Contrast-Induced Nephropathy (REICIN) study is the largest prospective multicenter data base for CIN flowing coronary angiography (CAG) or percutaneous coronary intervention (PCI). The REICIN study has the potential to characterize contemporary CIN incidence, modified risk factors and prognosis, so that to identify strategiaes to reduce risk of CIN following CAG/PCI.
详细描述
This is a multicenter prospective observational study collecting data on over 5000 CAG patients admitted to department of cardiology in 12 hospitals from January 2013. Data will be collected for more than 1 year on all patients undergoing CAG with or without PCI older than 18 years without baseline end-stage renal failure needing renal replacement therapy or renal transplantation. Data to be collected includes demographic information, admission diagnoses and co-morbidities, biomarkers and details on preventive hydration and medications used Contrast-induced nephropathy (CIN) is the primary endpoint, defined as a ≥ 0.5 mg/dL or 25% increase in serum creatinine (SCr) from baseline during the first 48 to 72 hours after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients referred to CAG or PCI;
- •Age ≥ 18 years
- •Submit informed consent and adhere to the study protocol
排除标准
- •Fail to undergo CAG/PCI or die during the procedure；
- •End-stage renal diseases or renal replacement；
- •Pre-procedural unstable renal funciton (acute increase in serum creatinine more than 0.5mg/ml in the past 24 h)；
- •Intravascular administration of a contrast medium within the previous 48 hours；
- •Allergic to contrast medium;
- •Pregnancy, lactation or malignant tumoror life expectancy< 1 year;
- •The use of renal toxicity drugs (non-steroidal anti-inflammatory drugs, aminoglycoside drugs, cyclosporine, cisplatin etc) within 48 h before cardiac catheter surgery and the whole process of the research;
- •Refer to receive renal artery angiography or surgical valve replacement in patients with rheumatic heart disease； For exclusion creteria 7, patients admited and taked aspirin are included in the study.
结局指标
主要结局
contrast-induced nephropathy
时间窗: 48-72 h
Contrast-Induced Nephropathy was defined as a ≥ 0.5 mg/dL or 25% increase in serum creatinine from baseline during the first 48 to 72 hours after the procedure.
次要结局
- contrast-induced acute kidney injury (CI-AKI0.3)(48h)
- Cystatin C based CI-AKI (CI-AKIcyc)(24-48h)
- The change of eGFR, calculate based on CrCl and serum cystatin C(48-72 h)
- Persistent CI-AKI (CI-AKIp)(3 months)
- In-hospital major adverse cardiovascular and clinical events(In-hospital)
- Follow-up major adverse cardiovascular and clinical events(>=1 year)
研究者
Jiyan Chen
MD
Guangdong Provincial People's Hospital