Coronary Artery Stenosis
Conditions
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.
Interventions
DRUGIopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
DRUGIodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iodixanol 320 Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure | 28 |
| Iopamidol 370 Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Missing NGAL measurement | 2 | 5 |
| Overall Study | Physician Decision | 3 | 5 |
Baseline characteristics
| Characteristic | Iodixanol 320 | Iopamidol 370 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Continuous | 71.1 years STANDARD_DEVIATION 7.4 | 73.3 years STANDARD_DEVIATION 10 | 72.2 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Canada | 10 participants | 9 participants | 19 participants |
| Region of Enrollment United States | 18 participants | 20 participants | 38 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
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.
Time frame: Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose
Population: A total of 41 patients met the evaluable criteria for NGAL analysis, 18 patients that were administered iopamidol 370, and 23 patients that were administered iodixanol 320.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 2 hours post-dose | -27.76 ng/mL | Standard Deviation 51.89 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 4 hours post-dose | -27.06 ng/mL | Standard Deviation 46.03 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 6 hours post-dose | -15.83 ng/mL | Standard Deviation 47.06 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 24 hours post-dose | 15.89 ng/mL | Standard Deviation 78.14 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 48 hours post-dose | 22.88 ng/mL | Standard Deviation 59.34 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 72 hours post-dose | 22.32 ng/mL | Standard Deviation 60.51 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 72 hours post-dose | NA ng/mL | — |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 24 hours post-dose | -5.85 ng/mL | Standard Deviation 15.68 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 2 hours post-dose | -11.11 ng/mL | Standard Deviation 16.32 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 6 hours post-dose | -6.88 ng/mL | Standard Deviation 10.61 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 4 hours post-dose | -10.68 ng/mL | Standard Deviation 15.1 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 48 hours post-dose | -0.85 ng/mL | Standard Deviation 16.57 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 4 hours post-dose | -14.66 ng/mL | Standard Deviation 42.24 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 6 hours post-dose | -17.61 ng/mL | Standard Deviation 37.28 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 24 hours post-dose | 35.06 ng/mL | Standard Deviation 85.39 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 72 hours post-dose | 33.18 ng/mL | Standard Deviation 52.92 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 48 hours post-dose | 54.54 ng/mL | Standard Deviation 52.62 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 2 hours post-dose | -11.84 ng/mL | Standard Deviation 30.49 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 48 hours post-dose | 11.18 ng/mL | Standard Deviation 21.6 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 72 hours post-dose | NA ng/mL | — |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 4 hours post-dose | -4.87 ng/mL | Standard Deviation 15.06 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 24 hours post-dose | 4.46 ng/mL | Standard Deviation 18.03 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 2 hours post-dose | -8.23 ng/mL | Standard Deviation 9.9 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 6 hours post-dose | -7.70 ng/mL | Standard Deviation 7.44 |