Chronic Kidney Diseases, Coronary Artery Disease, Renal Failure
Conditions
Keywords
CKD, CAD, AKI, nephroprotection, impella, protected PCI
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.
Interventions
OTHERObservational
Observational
Sponsors
German Heart Center
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the Inclusion Criteria to participate in the trial. 1. Age ≥18 years and \<90 years 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrarenal Resistive Index (RI) | immediately and 24 hours after PCI | unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity. |
| Acute Kidney Injury | 48 hours respectively within 7 days | Increase in serum creatinine by at least 0.3 mg/dl within 48 hours, or increase in serum creatinine at least 1.5 times the known or assumed baseline value within seven days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless); | maximum change 24 hours post intervention compared to baseline | Relation calculated by Pearson correlation |
| Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score | maximum change day 1 or day 2 post intervention compared to baseline | — |
| Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles) | maximum change 24 hours post intervention compared to baseline | Relation calculated by Pearson correlation |
| Hierarchical clinical endpoint of AKI > rise of urinary α2macroglobulin concentration post PCI > increase of RI post PCI in Impella-protected patients versus non-Impella-protected patients matched by Mehran score | maximum change day 1 or day 2 post intervention compared to baseline | — |
| Change of RI (Intrarenal Resistive Index) by Impella comparing RI at performance levels P0 and P9 at the begin of the intervention in every Impella-protected patient. | during Impella treatment (up to 14 days) | — |
| Length of stay in relation to RI and classic Mehran score. | Hospital admission until discharge (assessed up to maximum of 10 days) | — |
| α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless). | maximum change 24 hours post intervention compared to baseline | Relation calculated by Pearson correlation |
Countries
Germany
Contacts
Primary ContactAmin Polzin, Prof.
Backup ContactLisa Dannenberg, PD
Outcome results
None listed