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

This study has been completed.
Sponsor:
Information provided by:
National Heart Institute, Mexico
ClinicalTrials.gov Identifier:
NCT00467311
First received: April 27, 2007
Last updated: May 6, 2008
Last verified: May 2008
  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

Study Type: Observational
Study Design: Time Perspective: 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:

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00467311

Locations
Mexico
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

Publications:

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

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

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Contrast Media
Cystatins
Cysteine Proteinase Inhibitors
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014