Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467311
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2007-04-27
Brief Title:
Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients
Sponsor:
National Heart Institute Mexico
Organization:
National Heart Institute Mexico
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Thats 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 its filtered through the glomerular membrane without restriction and its fully reabsorbed in the proximal tubule thats why its 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
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 its filtered through the glomerular membrane without restriction and its fully reabsorbed in the proximal tubule thats why its 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None