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

Acute Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467311
• Other study ID #: 07552
• Status: Completed
• Phase: N/A
• First received: April 27, 2007
• Last updated: May 6, 2008
• Start date: December 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: National Heart Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Contrast Induced Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
Mexico	Ignacio Chávez National Institute of Cardiology	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Institute, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (14)

Bökenkamp 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. — View Citation

Coll E, Botey A, Alvarez L, Poch E, Quintó 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. — View Citation

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. — View Citation

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. — View Citation

Herget-Rosenthal S, Marggraf G, Hüsing J, Göring 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mares J, Stejskal D, Vavrousková J, Urbánek K, Herzig R, Hlustík 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. — View Citation

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. — View Citation

Rickli H, Benou K, Ammann P, Fehr T, Brunner-La Rocca HP, Petridis H, Riesen W, Wüthrich 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. — View Citation

Schück 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. — View Citation

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. — View Citation

Villa P, Jiménez 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

External Links

•   National Institute of Cardiology