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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01136915
• Other study ID #: IOP-118
• Status: Terminated
• Phase: Phase 4
• First received: June 2, 2010
• Last updated: February 20, 2014
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2014
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provides written Informed Consent

• Is at least 18 years of age;

• Is scheduled for or likely to undergo percutaneous coronary intervention;

• Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

• Is a pregnant or lactating female

• Has a history of severe congestive heart failure

• Has a history of hyperthyroidism

• Has unstable renal function

• Has a history of hypersensitivity to iodinated contrast agents

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:
• Iopamidol 370
one time administration for PCI
• Iodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection

Locations

Country	Name	City	State
Canada	Institu De Cardiologie De Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

Canada, 

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 in Comparison to a Non-ionic, Iso-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 contrast media.	Baseline and 2,4,6,24, 48, and 72 hours post-dose	Yes