Monitoring kidney health during heart procedures
IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
This study is trying to see if a new way to measure kidney health can help protect people with chronic kidney disease from kidney injury during heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT06599424 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the intrarenal resistive index (RI) as a marker for patients at risk of contrast-associated acute kidney injury (CA-AKI) during percutaneous coronary interventions (PCI). It seeks to integrate elements of the Mehran AKI risk score into a single parameter that can be easily measured. The study also investigates the potential nephroprotective effects of Impella support in reducing elevated RI and improving kidney outcomes. By understanding these mechanisms, the study hopes to tailor nephroprotection strategies for patients with chronic kidney disease who require PCI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 who are scheduled for a PCI procedure within a week.
Not a fit: Patients with severe chronic kidney disease, recent acute kidney injury, or those experiencing cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney protection strategies for patients undergoing heart procedures, potentially reducing the incidence of CA-AKI.
How similar studies have performed: Previous studies have shown protective effects of Impella support in reducing CA-AKI, suggesting that this approach may have merit.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Berlin and 1 other locations
- Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite — Berlin, Germany (Recruiting)
- Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Principal investigator: Amin Polzin, Prof. — Division of Cardiology, Pulmonary Disease and Vascular Medicine
- Study coordinator: Amin Polzin, Prof.
- Email: Amin.Polzin@med.uni-duesseldorf.de
- Phone: +49211-81-18800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.