Clinical trial NCT04928118: Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Contrast-induced Acute Kidney Injury (CI-AKI)
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2021-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo Impella assisted PCI procedure

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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%

Exclusion Criteria:-

* 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

Primary outcomes:
measure: Renal blood flow (RBF)
timeFrame: during PCI up to 5 hours
Secondary outcomes:
Other outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: up to 72 hours after PCI
measure: Anatomical changes
timeFrame: 3 days
measure: Renal oxygen delivery (ROD)
timeFrame: during PCI up to 5 hours
measure: Renal oxygen consumption (ROC)
timeFrame: during PCI up to 5 hours
measure: Renal oxygen extraction (ROE)
timeFrame: during PCI up to 5 hours
measure: Renal vascular resistance (RVR)
timeFrame: during PCI up to 5 hours
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Lorenzo Azzalini, MD
role: PRINCIPAL_INVESTIGATOR
References: