Kidney Damage in Patients With Normal 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 Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Inclusion Criteria:

• Provides written Informed Consent and is willing to comply with protocol requirements;
• Is at least 18 years of age;
• Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
• Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

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