NCT01136915

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DRUG	Iopamidol 370	one time administration for PCI
DRUG	Iodixanol 320	Iodixanol 320 single injection for percutaneous coronary injection

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-06-04
• Last updated: 2014-03-17
• Results posted: 2014-01-14

Locations

1 site across 1 country: Canada