Clinical Validation of the RENISCHEM L-FABP POC Assay

This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.

Inclusion Criteria: * Patients age 18 or older on the day of the procedure * Undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, TAVR or TAVI, with planned use of radiocontrast media within the next 30 days * Able to provide informed consent * Available to participate in follow-up visits * eGFR \< 45 within the last 90 days, or * eGFR \< 60 within the last 90 days with at least one (1) of the following risk factors: * Diabetes * Heart failure (acute or chronic) * Anemia (hemoglobin \< 12 g/dL for females and \< 13 g/dL for males) within the last 90 days * Age \> 75 on the day of the procedure Exclusion Criteria: * Patient on dialysis or with eGFR \< 15 within the last 30 days * History of renal transplant * Current use of immunosuppressive drugs other than prednisone \< 10 mg/day * Current clinically significant infection (including HIV, hepatitis) * Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria * Known or suspected nephritic or nephrotic syndrome. * A current post-renal etiology of renal impairment * Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated * Females that are known to be pregnant or nursing * Participation within the last 30 days in another clinical trial involving use of any drug known to affect AKI and/or device known to affect AKI