Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients - Full Text View

Purpose

Hypothesis:

Cystatin C compared with creatinine is a better and earlier marker of contrast-induced nephropathy in high and intermedium risk cardiac catheterization patients.

Primary Objective:

Establish if Cystatin C is superior detecting contrast-induced nephropathy than creatinine in high and intermedium risk cardiac catheterization patients.

Condition
Contrast Induced Nephropathy Acute Renal Failure

Study Type:	Observational
Study Design:	Time Perspective: Cross-Sectional
Official Title:	Diagnostic, Transversal, Comparative, Not Randomized Trial for the Evaluation of Cystatin C as an Early Marker of Contrast-Medium Nephropathy in High-and-Intermedium-Risk Patients Undergoing to Cardiac Catheterization

Further study details as provided by National Heart Institute, Mexico:

Enrollment:	66
Study Start Date:	December 2006
Study Completion Date:	April 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Contrast induced-nephropathy is a complication that is underestimated in clinical practice after cardiac catheterization. During the last 30 years, because of the increasing use of contrast medium for diagnostic and therapeutic procedures, this has become the third in-hospital cause of acute renal failure (12%). That's why, it is necessary to establish an earlier marker of renal dysfunction that can help us in the diagnosis and allow us to initiate the appropriate therapeutics, because depending on the severity of the renal damage, it can increase the cardiovascular risk and morbidity.

The risk of contrast medium nephropathy is still present even with the use of low osmolarity contrast media, and many patients increase their in-hospital days, costs and hemodialysis requirement.

Cystatin C is a non glucosylated protein produced in nucleated cells in a constant rate, and because of its low molecular weight it's filtered through the glomerular membrane without restriction and it's fully reabsorbed in the proximal tubule, that's why it's considered an excellent marker evaluating the glomerular filtration rate in patients with acute renal failure during the first 24-48 hours.

We propose that Cystatin C can be useful as an earlier and superior marker of contrast-induced nephropathy in high and intermedium cardiac catheterization patients.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients over 20 years old with an indication for coronariography and/or percutaneous coronary intervention, and with a MEHRAN contrast-induced nephropathy score from six to fifteen.

Criteria

Inclusion Criteria:

Age over 20 years old
Indication for coronariography and/or percutaneous coronary intervention
Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
A MEHRAN contrast-induced nephropathy score from six to fifteen.

Exclusion Criteria:

N-Acetylcystein and Fenoldopam pre-medication
Low risk patients according MEHRAN classification
Cardiogenic and septic shock
Acute renal failure by any other cause
Patients with chronic kidney failure requiring any kind of dialysis
Patients unable to complete follow-up
Exposure to contrast media 48 hours prior to study
Patients unable to give consent
Receiving contrast media other than non-ionic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467311

Locations

Mexico
Ignacio Chávez National Institute of Cardiology
Mexico City, DF, Mexico, 01480

Sponsors and Collaborators

National Heart Institute, Mexico

Investigators

Principal Investigator:	Jhonathan L Uribe-González, MD, MSc	Ignacio Chávez National Institute of Cardiology
Study Chair:	Jorge G Hernández, MD, FSCAI	Ignacio Chávez National Institute of Cardiology
Study Director:	Marco A Martínez-Rios	Ignacio Chávez National Institute of Cardiology
Principal Investigator:	Marco A Peña-Duque, MD	Ignacio Chávez National Institute of Cardiology

More Information

Publications:

Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. Review. Erratum in: CMAJ. 2005 Nov 8;173(10):1210.

Rickli H, Benou K, Ammann P, Fehr T, Brunner-La Rocca HP, Petridis H, Riesen W, Wuthrich RP. Time course of serial cystatin C levels in comparison with serum creatinine after application of radiocontrast media. Clin Nephrol. 2004 Feb;61(2):98-102.

Schuck O, Teplan V, Jabor A, Stollova M, Skibova J. Glomerular filtration rate estimation in patients with advanced chronic renal insufficiency based on serum cystatin C levels. Nephron Clin Pract. 2003;93(4):c146-51.

Han WK, Bonventre JV. Biologic markers for the early detection of acute kidney injury. Curr Opin Crit Care. 2004 Dec;10(6):476-82. Review.

Villa P, Jimenez M, Soriano MC, Manzanares J, Casasnovas P. Serum cystatin C concentration as a marker of acute renal dysfunction in critically ill patients. Crit Care. 2005 Apr;9(2):R139-43. Epub 2005 Feb 7.

Shlipak MG, Sarnak MJ, Katz R, Fried LF, Seliger SL, Newman AB, Siscovick DS, Stehman-Breen C. Cystatin C and the risk of death and cardiovascular events among elderly persons. N Engl J Med. 2005 May 19;352(20):2049-60.

Lameire N, Hoste E. Reflections on the definition, classification, and diagnostic evaluation of acute renal failure. Curr Opin Crit Care. 2004 Dec;10(6):468-75. Review. No abstract available.

Loew M, Hoffmann MM, Koenig W, Brenner H, Rothenbacher D. Genotype and plasma concentration of cystatin C in patients with coronary heart disease and risk for secondary cardiovascular events. Arterioscler Thromb Vasc Biol. 2005 Jul;25(7):1470-4. Epub 2005 Apr 28.

Mares J, Stejskal D, Vavrouskova J, Urbanek K, Herzig R, Hlustik P. Use of cystatin C determination in clinical diagnostics. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Dec;147(2):177-80. Review.

Hoek FJ, Kemperman FA, Krediet RT. A comparison between cystatin C, plasma creatinine and the Cockcroft and Gault formula for the estimation of glomerular filtration rate. Nephrol Dial Transplant. 2003 Oct;18(10):2024-31.

Bokenkamp A, Domanetzki M, Zinck R, Schumann G, Byrd D, Brodehl J. Cystatin C--a new marker of glomerular filtration rate in children independent of age and height. Pediatrics. 1998 May;101(5):875-81.

Herget-Rosenthal S, Marggraf G, Husing J, Goring F, Pietruck F, Janssen O, Philipp T, Kribben A. Early detection of acute renal failure by serum cystatin C. Kidney Int. 2004 Sep;66(3):1115-22.

Coll E, Botey A, Alvarez L, Poch E, Quinto L, Saurina A, Vera M, Piera C, Darnell A. Serum cystatin C as a new marker for noninvasive estimation of glomerular filtration rate and as a marker for early renal impairment. Am J Kidney Dis. 2000 Jul;36(1):29-34.

O'Riordan SE, Webb MC, Stowe HJ, Simpson DE, Kandarpa M, Coakley AJ, Newman DJ, Saunders JA, Lamb EJ. Cystatin C improves the detection of mild renal dysfunction in older patients. Ann Clin Biochem. 2003 Nov;40(Pt 6):648-55.

ClinicalTrials.gov Identifier:	NCT00467311 History of Changes
Other Study ID Numbers:	07552
Study First Received:	April 27, 2007
Last Updated:	May 6, 2008
Health Authority:	Mexico: Ethics Committee

Keywords provided by National Heart Institute, Mexico:

Contrast-induced nephropathy
Cystatin C
Contrast media
Creatinine
Cardiac Catheterization

Additional relevant MeSH terms:

Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Urologic Diseases
Cystatins

Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013