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

Sponsor
National Heart Institute, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT00467311
Collaborator
(none)
66
1
16
4.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    66 participants
    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
    Study Start Date :
    Dec 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2007
    Actual Study Completion Date :
    Apr 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00467311
      Other Study ID Numbers:
      • 07552
      First Posted:
      Apr 30, 2007
      Last Update Posted:
      May 8, 2008
      Last Verified:
      May 1, 2008

      Study Results

      No Results Posted as of May 8, 2008