Clinical trial NCT00467311: Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Induced Nephropathy
Acute Renal Failure
Keywords: Contrast-induced nephropathy
Cystatin C
Contrast media
Creatinine
Cardiac Catheterization
Lead sponsor: National Heart Institute, Mexico
Sponsor class: OTHER_GOV
First posted: 2007-04-30
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Ignacio Chávez National Institute of Cardiology
state: DF
Study officials:
affiliation: Ignacio Chávez National Institute of Cardiology
name: Jhonathan L Uribe-González, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ignacio Chávez National Institute of Cardiology
name: Jorge G Hernández, MD, FSCAI
role: STUDY_CHAIR
affiliation: Ignacio Chávez National Institute of Cardiology
name: Marco A Martínez-Rios
role: STUDY_DIRECTOR
affiliation: Ignacio Chávez National Institute of Cardiology
name: Marco A Peña-Duque, MD
role: PRINCIPAL_INVESTIGATOR
References:
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