Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04928118
Status:
WITHDRAWN
Last Update Posted:
2022-02-04
First Post:
2021-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI may be leaving the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: