Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI

NCT ID: NCT04928118

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-10-31

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.

Conditions

Contrast-induced Acute Kidney Injury (CI-AKI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Impella protected Percutaneous coronary intervention (PCI)

Patients undergoing Impella protected PCI as deemed necessary by interventional cardiologist - VCU Medical Center case based standard of care

Evaluate the blood flow and pressure into kidneys

Intervention Type: OTHER

Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance.

A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content.

Interventions

Evaluate the blood flow and pressure into kidneys

Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance.

A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Azzalini, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Other Identifiers

HM20021800

Identifier Type: -

Identifier Source: org_study_id