Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599424
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the hypothesis is that elevation of the intrarenal resistive index RI characterizes patients at elevated risk for subsequent CA-AKI and integrates items of the Mehran AKI risk score into a single readily obtainable parameter Impella-mediated nephroprotection confers to reduction of elevated RI by restoration of intrarenal venous flow profile
Detailed Description:
Contrast-associated acute kidney injury CA-AKI occurs in up to 10 of patients undergoing percutaneous coronary intervention PCI for coronary revascularization CA-AKI is associated with impaired long-term outcome This causes so-called Renalism describing the fact that patients with chronic kidney disease CKD in need of live-saving revascularizations are not offered PCI procedures in the risk of imminent CA-AKI
Retrospective studies and one-single-center pilot study described protective effects of Impella-protected PCI to reduce the incidence of CA-AKI However mechanisms involved of nephroprotection by Impella remain obscure Deciphering these is a prerequisite to tailor nephroprotection to the patients in need and to gain a label for nephroprotection by Impella
Retrospective studies and one-single-center pilot study described protective effects of Impella-protected PCI to reduce the incidence of CA-AKI However mechanisms involved of nephroprotection by Impella remain obscure Deciphering these is a prerequisite to tailor nephroprotection to the patients in need and to gain a label for nephroprotection by Impella
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None