Kidney Damage in Patients With Moderate Fall in eGFR
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | November 2010 |
| End Date: | August 2012 |
| Contact: | Tara Rogers |
| Email: | tara.rogers@diag.bracco.com |
| Phone: | 609-514-2577 |
A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
This is a pilot study having a randomized, double-blind parallel group comparison of two
iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients
enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59
mL/min. Statistical summaries will be presented to analyze the various lab tests results
for the two groups.
Inclusion Criteria:
- At least 18 years of age and provides informed consent
- Scheduled to undergo percutaneous coronary intervention
- Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or
equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared
Exclusion Criteria:
- Pregnant or lactating females
- Severe congestive heart failure
- History of hyperthyroidism;
- Unstable renal function
- Emergency PCI
- History of hypersensitivity to iodinated contrast agents
- Receiving diuretics to prevent acute renal injury
We found this trial at
2
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