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

NCT06599424 | Recruiting

• 1 other identifier: REDETERMINE
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Diseases; Renal Failure; Coronary Artery Disease

Keywords

CKD; CAD; AKI; nephroprotection; impella; protected PCI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)

  maximum change 24 hours post intervention compared to baseline

• α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).

  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);

  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)

Study Arms (2)

subjects with PCI

Other: Observational

subjectis with Impella-protected PCI

Other: Observational

Interventions

Observational OTHER

Observational

subjectis with Impella-protected PCI; subjects with PCI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for PCI or Impella-protected PCI

You may qualify if:

• Age ≥18 years and \<90 years
• Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.

You may not qualify if:

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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• German Heart Center: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (2)

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, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Coronary Artery Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• 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

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)