Coronary Artery Stenosis
Conditions
Brief 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.
Interventions
DRUGNon ionic contrast media comparator
One time administration for PCI
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iodixanol 320 NGAL Evaluable Population Non-ionic contrast media comparator: one time administration for PCI | 21 |
| Iopamidol 370 NGAL Evaluable Population Non-ionic contrast media comparator: one time administration for PCI | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Iodixanol 320 NGAL Evaluable Population | Iopamidol 370 NGAL Evaluable Population | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age Continuous | 62.0 years STANDARD_DEVIATION 10.65 | 63.4 years STANDARD_DEVIATION 12.82 | 62.7 years STANDARD_DEVIATION 11.66 |
| Region of Enrollment Italy | 4 participants | 5 participants | 9 participants |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 1 / 25 | 0 / 24 |
Outcome results
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.
Time frame: Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 48 hours post-dose | 18.76 ng/mL | Standard Deviation 62.77 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 24 hours post-dose | 28.35 ng/mL | Standard Deviation 39.21 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 2 hours post-dose | -14.84 ng/mL | Standard Deviation 35.46 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 6 hours post-dose | -16.36 ng/mL | Standard Deviation 28.77 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 72 hours post-dose | 18.34 ng/mL | Standard Deviation 52.28 |
| Iodixanol 320 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 4 hours post-dose | -12.86 ng/mL | Standard Deviation 30.57 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 72 hours post-dose | NA ng/mL | — |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 2 hours post-dose | -17.71 ng/mL | Standard Deviation 49.04 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 24 hours post-dose | -2.10 ng/mL | Standard Deviation 46.94 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 48 hours post-dose | -14.60 ng/mL | Standard Deviation 34.69 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 4 hours post-dose | -29.33 ng/mL | Standard Deviation 64.65 |
| Iodixanol 320 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 6 hours post-dose | -17.90 ng/mL | Standard Deviation 51.38 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 6 hours post-dose | -5.60 ng/mL | Standard Deviation 24.5 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 2 hours post-dose | -9.98 ng/mL | Standard Deviation 22.8 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 72 hours post-dose | 26.59 ng/mL | Standard Deviation 48.13 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 48 hours post-dose | 34.03 ng/mL | Standard Deviation 46.27 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 4 hours post-dose | -5.93 ng/mL | Standard Deviation 26.62 |
| Iopamidol 370 Serum NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 24 hours post-dose | 20.15 ng/mL | Standard Deviation 32.74 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 4 hours post-dose | -2.70 ng/mL | Standard Deviation 7.09 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 24 hours post-dose | 2.31 ng/mL | Standard Deviation 8.7 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 48 hours post-dose | 7.37 ng/mL | Standard Deviation 22.84 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 2 hours post-dose | -2.37 ng/mL | Standard Deviation 5.45 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 6 hours post-dose | -2.29 ng/mL | Standard Deviation 7.66 |
| Iopamidol 370 Urine NGAL | Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. | 72 hours post-dose | NA ng/mL | — |