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Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients
This study has been completed.
First Received: April 27, 2007   Last Updated: May 6, 2008   History of Changes
Sponsored by: National Heart Institute, Mexico
Information provided by: National Heart Institute, Mexico
ClinicalTrials.gov Identifier: NCT00467311
  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

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources
Study Type: Observational
Study Design: 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

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, DF
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

Additional 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.

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

Keywords provided by National Heart Institute, Mexico:
Contrast-induced nephropathy
Cystatin C
Contrast media
Creatinine
Cardiac Catheterization

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Salicylic Acid
Renal Insufficiency, Acute
Kidney Failure, Acute
Kidney Diseases
Cystatins
Protease Inhibitors
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Cysteine Proteinase Inhibitors
Enzyme Inhibitors
Renal Insufficiency, Acute
Kidney Failure, Acute
Kidney Diseases
Cystatins
Pharmacologic Actions
Protease Inhibitors
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009