A Zero Acute Kidney Injury (Zero-AKI) Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury (AKI)
研究概览
简要总结
The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.
详细描述
This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach.
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
- •Consecutive patients undergoing elective and urgent (i.e., non-emergent) PCI
- •Age >18 years
- •eGFR <60 ml/min/1.73 m2
- •Angina or equivalent and/or documentation of inducible myocardial ischemia
- •Presence of =1 coronary stenosis, evaluated >70% by visual estimation (on a previously performed coronary angiography) or with an FFR =0.80
- •ability to provide written informed consent
排除标准
- •Emergent PCI due to either hemodynamic instability, ST-elevation myocardial infarction or sudden cardiac death
- •PCI on chronic total occlusion
- •Prior PCI within 3 weeks
- •Age >90 years
- •Left ventricular ejection fraction <20%
- •Need for mechanical circulatory support
- •Pregnancy
- •Prisoners
- •Non-English speaking patients
- •Inability to provide written informed consent
结局指标
主要结局
Acute Kidney Injury (AKI)
时间窗: Up to 72 hours after the procedure
Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI
次要结局
未报告次要终点