Kidney Damage in Patients With Moderate Fall in eGFR

Coronary Artery Stenosis Clinical Trial

Official title:

Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136876
• Other study ID #: IOP-117
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Drug:
• Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
• Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec
United States	UMDNJ - RWJ Medical School	New Brunswick	New Jersey
United States	Research Cooperative, St. John's Hospital	Springfield	Illinois
United States	The Institute for Clinical Research at Holy Name Medical Center	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration	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 contrast media.	Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose