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OpenTrials
Completed

NCT Number: NCT00467311

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ignacio Chávez National Institute of Cardiology

Mexico City, 01480, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Heart Institute, Mexico

Other Gov

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 30, 2007
Registry last updated
May 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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