Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2021-10-01
2025-12-31
Brief Summary
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Detailed Description
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Subjects will be recruited prospectively based on pre-specified enrollment criteria. Blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care L-FABP measurements on urine samples.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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RENISCHEM L-FABP POC Test
Point-of-care test cassette with quantitative reader used for the measurement of L-type fatty acid binding protein (L-FABP) in human urine specimens.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Timewell Medical Co., Ltd.
UNKNOWN
Hikari Dx, Inc.
OTHER
Responsible Party
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Principal Investigators
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Peter McCullough
Role: PRINCIPAL_INVESTIGATOR
Independent
Locations
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Chandler Regional Medical Center
Chandler, Arizona, United States
John Muir Health
Concord, California, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
University of Florida at Jacksonville
Jacksonville, Florida, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey Dahlen, Ph.D.
Role: primary
Jeffrey DAHLEN, Ph.D.
Role: primary
Jeffrey Dahlen, Ph.D.
Role: primary
Jeffrey Dahlen, Ph.D.
Role: primary
Jeffrey Dahlen, Ph.D.
Role: primary
Jeffrey Dahlen, Ph.D.
Role: primary
References
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Noiri E, Doi K, Negishi K, Tanaka T, Hamasaki Y, Fujita T, Portilla D, Sugaya T. Urinary fatty acid-binding protein 1: an early predictive biomarker of kidney injury. Am J Physiol Renal Physiol. 2009 Apr;296(4):F669-79. doi: 10.1152/ajprenal.90513.2008. Epub 2008 Nov 19.
Yamamoto T, Noiri E, Ono Y, Doi K, Negishi K, Kamijo A, Kimura K, Fujita T, Kinukawa T, Taniguchi H, Nakamura K, Goto M, Shinozaki N, Ohshima S, Sugaya T. Renal L-type fatty acid--binding protein in acute ischemic injury. J Am Soc Nephrol. 2007 Nov;18(11):2894-902. doi: 10.1681/ASN.2007010097. Epub 2007 Oct 17.
Fujita D, Takahashi M, Doi K, Abe M, Tazaki J, Kiyosue A, Myojo M, Ando J, Fujita H, Noiri E, Sugaya T, Hirata Y, Komuro I. Response of urinary liver-type fatty acid-binding protein to contrast media administration has a potential to predict one-year renal outcome in patients with ischemic heart disease. Heart Vessels. 2015 May;30(3):296-303. doi: 10.1007/s00380-014-0484-9. Epub 2014 Feb 20.
Kamijo-Ikemori A, Hashimoto N, Sugaya T, Matsui K, Hisamichi M, Shibagaki Y, Miyake F, Kimura K. Elevation of urinary liver-type fatty acid binding protein after cardiac catheterization related to cardiovascular events. Int J Nephrol Renovasc Dis. 2015 Aug 18;8:91-9. doi: 10.2147/IJNRD.S88467. eCollection 2015.
Manabe K, Kamihata H, Motohiro M, Senoo T, Yoshida S, Iwasaka T. Urinary liver-type fatty acid-binding protein level as a predictive biomarker of contrast-induced acute kidney injury. Eur J Clin Invest. 2012 May;42(5):557-63. doi: 10.1111/j.1365-2362.2011.02620.x. Epub 2011 Nov 10.
Nakamura T, Sugaya T, Node K, Ueda Y, Koide H. Urinary excretion of liver-type fatty acid-binding protein in contrast medium-induced nephropathy. Am J Kidney Dis. 2006 Mar;47(3):439-44. doi: 10.1053/j.ajkd.2005.11.006.
Other Identifiers
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TWM-001
Identifier Type: -
Identifier Source: org_study_id
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