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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bracco Diagnostics, Inc
- Enrollment
- 57
- Locations
- 4
- Primary Endpoint
- Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
Study Overview
Brief Summary
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Iopamidol
Non-ionic low-osmolar iodinated contrast media
Intervention: Iopamidol (Drug)
Iodixanol
Non-ionic iso-osmolar iodinated contrast media comparator
Intervention: Iodixanol-320 (Drug)
Outcomes
Primary Outcomes
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
Time Frame: 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 contrast media.
Secondary Outcomes
No secondary outcomes reported