IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chronic Kidney Diseases; Renal Failure
• Intervention / Treatment: Other: Observational

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.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Amin Polzin, Prof.; Phone Number: +49211-81-18800; Email: Amin.Polzin@med.uni-duesseldorf.de
• Study Contact Backup: Name: Lisa Dannenberg, PD; Phone Number: +49211-81-05315; Email: LisaKristina.Dannenberg@med.uni-duesseldorf.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
    • Contact: Carsten Skurk, Prof.; Phone Number: +49 (0) 30 - 450 513702; Email: carsten.skurk@charite.de
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
    • Contact: Amin Polzin, Prof.; Phone Number: +49211-81-18800; Email: Amin.Polzin@med.uni-duesseldorf.de
    • Contact: Lisa Dannenberg, PD; Phone Number: +49211-81-05315; Email: LisaKristina.Dannenberg@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for PCI or Impella-protected PCI

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subjects with PCI	Other: Observational; Observational
subjectis with Impella-protected PCI	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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)

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Charite University, Berlin, Germany; German Heart Center
• Investigators: Study Chair: Malte Kelm, Prof., Division of Cardiology, Pulmonary Disease and Vascular Medicine; Principal Investigator: Amin Polzin, Prof., Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: CKD; CAD; AKI; nephroprotection; impella; protected PCI
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Coronary Disease; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: REDETERMINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No