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
| Registry | NCT01137786 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: triple, diagnostic |
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| Enrollment | 49 (Actual) |
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| Sponsor | Bracco Diagnostics, Inc (Industry) |
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| Conditions | Coronary Artery Stenosis |
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| Interventions | Non ionic contrast media comparator (Drug) |
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| Dates | start 2010-12-01, primary completion 2012-04-01, completion 2012-04-01, first posted 2010-06-04, last updated 2013-09-30 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Stenosis All trials of Non ionic contrast media comparator
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| IOPAMIDOL 370 | Active comparator | Drug: Non ionic contrast media comparator | |
| IODIXANOL 320 | Active comparator | Drug: Non ionic contrast media comparator | |
- Non ionic contrast media comparator (Drug), also known as Isovue 370: One time administration for PCI
- Non ionic contrast media comparator (Drug), also known as Visipaque 320: one time administration for PCI
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Iodixanol 320 | Iopamidol 370 |
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| Started | 25 | 24 |
| Completed | 24 | 21 |
| Not completed | 1 | 3 |
Outcome results
- Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. (Primary), Mean, ng/mL: Iodixanol 320 Serum NGAL -14.84 +/- 35.46; Iodixanol 320 Urine NGAL -17.71 +/- 49.04; Iopamidol 370 Serum NGAL -9.98 +/- 22.80; Iopamidol 370 Urine NGAL -2.37 +/- 5.45
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Iodixanol 320 | 0 | 1/25 (4.0%) | 0/25 (0.0%) |
| Iopamidol 370 | 0 | 0/24 (0.0%) | 0/24 (0.0%) |
Serious adverse events by term
| Term | Organ system | Iodixanol 320 | Iopamidol 370 |
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| Ventricular Fibrillation | Cardiac disorders | 1/25 | 0/24 |
+Locations (1)
| Facility | City | Country | Status |
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| Prairie Cardiovascular Consultants, Ltd. | Springfield, Illinois | United States | |
+Investigators