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A Study of Contrast-induced Acute Kidney Injury Prediction Using the RENISCHEM L-FABP Assay at the Point-of-Care (SAKURA-POC)

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this research is to help doctors and scientists learn about an investigational test called RENISCHEM L-FABP Test.  This test looks for a substance in urine that can help doctors tell if there is an increased risk of kidney injury after certain procedures that involve radiocontrast dye (dye given to make blood vessels visible during heart vessel catheterization).

We will investigate whether the levels of a substance called L-type fatty acid binding protein, or L-FABP, in urine can help doctors predict if there is an increased risk of kidney injury after certain catheterization procedures that involve radiocontrast dye. The L-FABP levels will be tested using a new test called the RENISCHEM L-FABP POC Test.

About 450 subjects will take part in this research across up to 10 facilities in the United States.

Details

Protocol number 20212233

Eligibility

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: o Diabetes (defined as history of diabetes, taking antidiabetic medications, fasting glucose > 126 mg/dL, or HbA1c > 6.5%)

o Heart failure (acute or chronic)

o Anemia (hemoglobin < 12 g/dL for females and < 13 g/dL for males) within the last 90 days

o Age > 75 on the day of the procedure

• eGFR < 90 within the last 90 days, with planned PCI, TAVR/TAVI, or bilateral lower extremity peripheral angiogram, AND concurrent diabetes (defined as history of diabetes, taking antidiabetic medications, fasting glucose > 126 mg/dL, or HbA1c > 6.5%)

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

 

Lead researcher

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    1

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  2. Step
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