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Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI

NCT04928118 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-02-04

No results posted yet for this study

Summary

Patients undergoing Percutaneous Coronary Intervention (PCI) are exposed to the risk of suffering from a damage to the kidneys which goes under the name of Contrast-Associated Acute Kidney Injury (CA-AKI), which is more common if the subject has advanced heart or kidney disease. Up to 1 high risk patient in 3 can suffer from CA-AKI. Impella is a pump which sustain the heart in the course of PCI in high risk individuals. Incidentally, Impella was shown to also reduce the incidence of CA-AKI. The reason why Impella protects the kidneys is not currently known. The investigators aim at understanding it through measurements of kidney blood flow and metabolism.

Conditions

  • Contrast-induced Acute Kidney Injury (CI-AKI)

Interventions

OTHER

Evaluate the blood flow and pressure into kidneys

Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance. A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content.

Sponsors & Collaborators

  • Abiomed Inc.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Lorenzo Azzalini, MD · Virginia Commonwealth University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-10-31
Completion
2024-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928118 on ClinicalTrials.gov