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

Last updated: September 12, 2024
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Hyponatremia

Atherosclerosis

Treatment

Observational

Clinical Study ID

NCT06599424
REDETERMINE
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 (incases, where AKI cannot be ruled out as a cause for elevated serum creatinine, arise or fall above 30% of a second serum creatinine measurement obtained within 12to 24 hours is regarded indicative of AKI).

  3. STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanicalcomplications of transmural infarction are present (e.g., VSD, papillary musclerupture, etc.)

  4. Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenousfluids or hemodynamic deterioration for any duration requiring pressors ormechanical circulatory support, including IABP)

  5. Cardiorespiratory arrest related to the current admission unless subject isextubated 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 studyof an investigational drug or device that has not reached its primary endpoint

  9. Any medical or psychiatric condition such as dementia, alcoholism or substance abusewhich 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 notin remission, etc.)

  11. Subject belongs to a vulnerable population (defined as individuals with mentaldisability, 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 hierarchicalstructure such as university students, subordinate hospital and laboratorypersonnel, employees of the Sponsor, members of the armed forces and persons kept indetention)

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: Observational
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite

    Berlin,
    Germany

    Active - Recruiting

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

    Duesseldorf, 40225
    Germany

    Active - Recruiting

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