Characterization Of The Hemodynamic Effects Of Impella On Renal Blood Flow And Oxygen Delivery And Risk Of Contrast-Associated Acute Kidney Injury Among Patients Undergoing Protected Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Renal blood flow (RBF)
研究概览
简要总结
Patients undergoing Percutaneous Coronary Intervention (PCI) are exposed to the risk of suffering from a damage to the kidneys which goes under the name of Contrast-Associated Acute Kidney Injury (CA-AKI), which is more common if the subject has advanced heart or kidney disease. Up to 1 high risk patient in 3 can suffer from CA-AKI. Impella is a pump which sustain the heart in the course of PCI in high risk individuals. Incidentally, Impella was shown to also reduce the incidence of CA-AKI. The reason why Impella protects the kidneys is not currently known. The investigators aim at understanding it through measurements of kidney blood flow and metabolism.
详细描述
Contrast-associated acute kidney injury (CA-AKI) is among the major determinants of morbidity after percutaneous coronary intervention (PCI). Patients undergoing complex, high-risk indicated procedures (CHIP) are exposed to an increased risk of CA-AKI. Recent observational data suggested that mechanical circulatory support (MCS) with Impella in the course of CHIP PCI, i.e. Impella-protected PCI, may abate the risk of CA-AKI. A direct effect of MCS in improving renal perfusion has been postulated, but mechanistic evidence on the pathophysiologic effects of Impella on kidney hemodynamics is lacking. The investigators hypothesize that such improved renal outcomes during Impella protected PCI are attributable to increased blood flow as well as increased oxygen delivery to the kidneys granted by MCS. The aim of the present study is to fully characterize the renal hemodynamics as well as renal oxygen delivery and consumption during Impella-protected PCI using state-of-the-art invasive measurements, and to correlate those with functional magnetic resonance imaging of the kidney.
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
- •Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program
- •Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature
- •LVEF ≤45% and estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 and ≥1 complexity feature
- •LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features
- •Complexity features
- •Planned treatment of ≥2 vessels
- •Left main PCI
- •Bifurcation intervention with 2-stent strategy
- •Planned use of atherectomy (rotational, orbital, laser)
- •Chronic total occlusion PCI
- •PCI on last remaining vessel
- •LVEDP >18 mmHg
- •Cardiac index <2.0 l/min/m2 or pulmonary artery O2 saturation <55%
排除标准
- •Pregnancy or lactation
- •Presence of non-MRI compatible implanted medical device
- •Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis
- •Chronic hemodialysis before the index procedure
- •Status post-renal transplant
- •Prisoners
结局指标
主要结局
Renal blood flow (RBF)
时间窗: during PCI up to 5 hours
thermodilution will be used to measure patterns of RBF in milliliters per minute
次要结局
未报告次要终点