Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients
NCT ID: NCT00467311
Last Updated: 2008-05-08
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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COMPLETED
66 participants
OBSERVATIONAL
2006-12-31
2008-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
85 Years
ALL
No
Sponsors
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National Heart Institute, Mexico
OTHER_GOV
Principal Investigators
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Jhonathan L Uribe-González, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Ignacio Chávez National Institute of Cardiology
Jorge G Hernández, MD, FSCAI
Role: STUDY_CHAIR
Ignacio Chávez National Institute of Cardiology
Marco A Martínez-Rios
Role: STUDY_DIRECTOR
Ignacio Chávez National Institute of Cardiology
Marco A Peña-Duque, MD
Role: PRINCIPAL_INVESTIGATOR
Ignacio Chávez National Institute of Cardiology
Locations
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Ignacio Chávez National Institute of Cardiology
Mexico City, Mexico City, Mexico
Countries
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References
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Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
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. doi: 10.5414/cnp61098.
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. doi: 10.1159/000070234.
Han WK, Bonventre JV. Biologic markers for the early detection of acute kidney injury. Curr Opin Crit Care. 2004 Dec;10(6):476-82. doi: 10.1097/01.ccx.0000145095.90327.f2.
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. doi: 10.1186/cc3044. 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. doi: 10.1056/NEJMoa043161.
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. doi: 10.1097/01.ccx.0000144939.24897.71. 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. doi: 10.1161/01.ATV.0000168416.74206.62. 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.
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. doi: 10.1093/ndt/gfg349.
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. doi: 10.1542/peds.101.5.875.
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. doi: 10.1111/j.1523-1755.2004.00861.x.
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. doi: 10.1053/ajkd.2000.8237.
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. doi: 10.1258/000456303770367243.
Related Links
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National Institute of Cardiology
Other Identifiers
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07552
Identifier Type: -
Identifier Source: org_study_id