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Sponsored by: |
National Heart Institute, Mexico |
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Information provided by: | National Heart Institute, Mexico |
ClinicalTrials.gov Identifier: | NCT00467311 |
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 |
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Contrast Induced Nephropathy Acute Renal Failure |
Study Type: | Observational |
Study Design: | 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 |
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) |
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.
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Mexico, DF | |
Ignacio Chávez National Institute of Cardiology | |
Mexico City, DF, Mexico, 01480 |
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 ID Numbers: | 07552 |
Study First Received: | April 27, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00467311 History of Changes |
Health Authority: | Mexico: Ethics Committee |
Contrast-induced nephropathy Cystatin C Contrast media Creatinine Cardiac Catheterization |
Renal Insufficiency Urologic Diseases Cysteine Salicylic Acid Renal Insufficiency, Acute |
Kidney Failure, Acute Kidney Diseases Cystatins Protease Inhibitors Kidney Failure |
Renal Insufficiency Molecular Mechanisms of Pharmacological Action Urologic Diseases Cysteine Proteinase Inhibitors Enzyme Inhibitors Renal Insufficiency, Acute |
Kidney Failure, Acute Kidney Diseases Cystatins Pharmacologic Actions Protease Inhibitors Kidney Failure |