Kidney Damage in Patients With Normal eGFR

Coronary Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137786
• Other study ID #: IOP-116
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2010
• Last updated: August 7, 2013
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Drug:
• Non ionic contrast media comparator
One time administration for PCI
• Non ionic contrast media comparator
one time administration for PCI

Locations

Country	Name	City	State
United States	Prairie Cardiovascular Consultants, Ltd.	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.	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.	Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose	Yes