Clinical trial NCT06599424: IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
Official title: IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Renal Failure
Coronary Artery Disease
Keywords: CKD
CAD
AKI
nephroprotection
impella
protected PCI
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Heart Center
name: Charite University, Berlin, Germany
First posted: 2024-09-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for PCI or 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.

Eligibility criteria: 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 Exclusion Criteria to participate in the trial.

1. Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
2. 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).
3. 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.)
4. 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)
5. Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable.
6. Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions.
7. Pregnant or child-bearing potential unless negative pregnancy test within 1 week
8. 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
9. 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
10. Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.)
11. 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)

Primary outcomes:
measure: Intrarenal Resistive Index (RI)
timeFrame: immediately and 24 hours after PCI
measure: Acute Kidney Injury
timeFrame: 48 hours respectively within 7 days
Secondary outcomes:
measure: Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)
timeFrame: maximum change 24 hours post intervention compared to baseline
measure: α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).
timeFrame: maximum change 24 hours post intervention compared to baseline
measure: NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless);
timeFrame: maximum change 24 hours post intervention compared to baseline
measure: Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score
timeFrame: maximum change day 1 or day 2 post intervention compared to baseline
measure: Length of stay in relation to RI and classic Mehran score.
timeFrame: Hospital admission until discharge (assessed up to maximum of 10 days)
measure: 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
timeFrame: maximum change day 1 or day 2 post intervention compared to baseline
measure: 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.
timeFrame: during Impella treatment (up to 14 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, Prof.
role: STUDY_CHAIR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Amin Polzin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: