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Clinical Trial Summary

This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04321148
Study type Interventional
Source Heinrich-Heine University, Duesseldorf
Contact Ralf Westenfeld, MD
Phone +2118118800
Email ctu@med.uni-duesseldorf.de
Status Recruiting
Phase N/A
Start date January 24, 2020
Completion date December 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04477603 - Impella ECP Early Feasibility Study N/A
Recruiting NCT06132568 - VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS) N/A
Recruiting NCT05727059 - Magenta Elevateā„¢ EFS in High-Risk PCI Patients N/A
Enrolling by invitation NCT05334784 - Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol N/A
Active, not recruiting NCT06099548 - Magenta Elevateā„¢ First-in-Human Clinical Study in High-Risk PCI Patients N/A