Overview
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.
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.
Eligibility
Inclusion Criteria:
Subjects must meet all of the Inclusion Criteria to participate in the trial.
- Age ≥18 years and <90 years
- Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.
Exclusion Criteria:
Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
- Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
- Patients with AKI within the last seven days prior screening or incipient AKI (in cases, where AKI cannot be ruled out as a cause for elevated serum creatinine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is regarded indicative of AKI).
- STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
- Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
- Cardiorespiratory arrest related to the current admission unless subject is extubated for >24 hours with full neurologic recovery and hemodynamically stable.
- Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions.
- Pregnant or child-bearing potential unless negative pregnancy test within 1 week
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
- Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
- Any non-cardiac condition with life expectancy <1 years (e.g., cirrhosis, cancer not in remission, etc.)
- Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)