Kidney Damage in Patients With Normal eGFR

Phase 4

Completed

• Conditions: Coronary Artery Stenosis
• Interventions: Drug: Non ionic contrast media comparator

• Registration Number: NCT01137786
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Study Start: 2010-12
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-05-22
• Results First Submitted QC: 2013-08-07
• Last Update Submitted: 2013-08-07
• Results First Posted: 2013-09-30
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOPAMIDOL 370	Non ionic contrast media comparator	-
IODIXANOL 320	Non ionic contrast media comparator	-

Primary Outcome Measures

Name	Time	Method
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.	Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose	Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.

Trial Locations

Locations (1)

Prairie Cardiovascular Consultants, Ltd.; 🇺🇸 Springfield, Illinois, United States