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| Name | Class |
|---|---|
| German Heart Center | OTHER |
| Charite University, Berlin, Germany | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subjects with PCI |
| ||
| subjectis with Impella-protected PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intrarenal Resistive Index (RI) | unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity. | immediately and 24 hours after PCI |
| Acute Kidney Injury | 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 | 48 hours respectively within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles) | Relation calculated by Pearson correlation | maximum change 24 hours post intervention compared to baseline |
| α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless). |
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Inclusion Criteria:
Subjects must meet all of the Inclusion Criteria to participate in the trial.
Exclusion Criteria:
Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
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Patients with indication for PCI or Impella-protected PCI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amin Polzin, Prof. | Contact | +49211-81-18800 | Amin.Polzin@med.uni-duesseldorf.de | |
| Lisa Dannenberg, PD | Contact | +49211-81-05315 | LisaKristina.Dannenberg@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Malte Kelm, Prof. | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Study Chair |
| Amin Polzin, Prof. | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite | Recruiting | Berlin | Germany |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Blood and urine samples
Relation calculated by Pearson correlation |
| maximum change 24 hours post intervention compared to baseline |
| NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless); | Relation calculated by Pearson correlation | maximum change 24 hours post intervention compared to baseline |
| 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 |
| Length of stay in relation to RI and classic Mehran score. | Hospital admission until discharge (assessed up to maximum of 10 days) |
| 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) |
| Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf | Recruiting | Düsseldorf | 40225 | Germany |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |