Kidney Damage In Patients With Severe Fall In eGFR

A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Inclusion Criteria:

• Provides written Informed Consent
• Is at least 18 years of age;
• Is scheduled for or likely to undergo percutaneous coronary intervention;
• Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

• Is a pregnant or lactating female
• Has a history of severe congestive heart failure
• Has a history of hyperthyroidism
• Has unstable renal function
• Has a history of hypersensitivity to iodinated contrast agents