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Contrast Induced NephropathyNCT00467311

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

An observational study of Contrast Induced Nephropathy and Acute Renal Failure, run by National Heart Institute, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 85 years
How many people
66 participants
Where
1 siteMexico
Study dates
Dec 2006to Apr 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Exposure to contrast media 48 hours prior to study
  • Patients unable to give consent
  • Receiving contrast media other than non-ionic

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Ignacio Chávez National Institute of Cardiology

    Mexico City, Mexico City, 01480

Other trials in Mexico

About this study

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

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.

Read the 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.

Keywords
Contrast-induced nephropathy, Cystatin C, Contrast media, Creatinine, Cardiac Catheterization
Medical subject headings
Acute Kidney Injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2007
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00467311
Sponsor's protocol ID
07552
Status last verified
May 2008
First submitted
27 Apr 2007
Last updated
8 May 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15911862

  • 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.

    PubMed 14989628

  • 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.

    PubMed 12759583

  • 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.

    PubMed 15616389

  • 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.

    PubMed 15774046

  • 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.

    PubMed 15901858

  • 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.

    PubMed 15616388

  • 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.

    PubMed 15860739

  • 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.

    PubMed 15037900

  • 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.

    PubMed 13679476

  • 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.

    PubMed 9565418

  • 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.

    PubMed 15327406

  • 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.

    PubMed 10873868

  • 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.

    PubMed 14629803

Questions about this trial

What is this clinical trial studying?

An observational study of Contrast Induced Nephropathy and Acute Renal Failure, run by National Heart Institute, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467311, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2008.

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