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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00467311
Enrollment
66
Registered
2007-04-30
Start date
2006-12-31
Completion date
2008-04-30
Last updated
2008-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Contrast Induced Nephropathy

Keywords

Contrast-induced nephropathy, Cystatin C, Contrast media, Creatinine, Cardiac Catheterization

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.

Interventions

None listed

Sponsors

National Heart Institute, Mexico
Lead SponsorOTHER_GOV

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026