Coronary Artery Stenosis
Conditions
Brief 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.
Interventions
DRUGIopamidol 370
one time administration for PCI
DRUGIodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection
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 * 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
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 in Comparison to a Non-ionic, Iso-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 contrast media. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iopamidol 370 Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention. | 8 |
| Iodixanol 320 Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criterion met | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Iopamidol 370 | Iodixanol 320 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 9.1 | 67.7 years STANDARD_DEVIATION 14.2 | 68.7 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Canada | 3 participants | 1 participants | 4 participants |
| Region of Enrollment China | 5 participants | 6 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
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.
Time frame: Baseline and 2,4,6,24, 48, and 72 hours post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iopamidol 370 Serum NGAL | 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. | 2 hours post-dose | -33.03 ng/mL | Standard Deviation 26.24 |
| Iopamidol 370 Serum NGAL | 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. | 4 hours post-dose | -6.39 ng/mL | Standard Deviation 33.26 |
| Iopamidol 370 Serum NGAL | 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. | 24 hours post-dose | 38.76 ng/mL | Standard Deviation 79.94 |
| Iopamidol 370 Serum NGAL | 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. | 72 hours post-dose | -16.88 ng/mL | Standard Deviation 33.76 |
| Iopamidol 370 Serum NGAL | 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. | 48 hours post-dose | 28.08 ng/mL | Standard Deviation 83.99 |
| Iopamidol 370 Serum NGAL | 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. | 6 hours post-dose | 13.03 ng/mL | Standard Deviation 32.6 |
| Iopamidol 370 Urine NGAL | 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. | 48 hours post-dose | 37.78 ng/mL | Standard Deviation 35.34 |
| Iopamidol 370 Urine NGAL | 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. | 24 hours post-dose | 22.51 ng/mL | Standard Deviation 61.31 |
| Iopamidol 370 Urine NGAL | 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. | 2 hours post-dose | -12.24 ng/mL | Standard Deviation 54.13 |
| Iopamidol 370 Urine NGAL | 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. | 72 hours post-dose | NA ng/mL | — |
| Iopamidol 370 Urine NGAL | 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. | 6 hours post-dose | -10.81 ng/mL | Standard Deviation 26.01 |
| Iopamidol 370 Urine NGAL | 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. | 4 hours post-dose | -29.98 ng/mL | Standard Deviation 50.98 |
| Iodixanol 320 Serum NGAL | 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. | 48 hours post-dose | -90.34 ng/mL | Standard Deviation 79.2 |
| Iodixanol 320 Serum NGAL | 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. | 2 hours post-dose | -103.23 ng/mL | Standard Deviation 45.63 |
| Iodixanol 320 Serum NGAL | 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. | 4 hours post-dose | -102.53 ng/mL | Standard Deviation 65.8 |
| Iodixanol 320 Serum NGAL | 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. | 6 hours post-dose | -45.53 ng/mL | Standard Deviation 101.85 |
| Iodixanol 320 Serum NGAL | 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. | 24 hours post-dose | -20.13 ng/mL | Standard Deviation 76.28 |
| Iodixanol 320 Serum NGAL | 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. | 72 hours post-dose | -25.89 ng/mL | Standard Deviation 161.56 |
| Iodixanol 320 Urine NGAL | 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. | 24 hours post-dose | -20.75 ng/mL | Standard Deviation 36.89 |
| Iodixanol 320 Urine NGAL | 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. | 4 hours post-dose | -52.09 ng/mL | Standard Deviation 65.31 |
| Iodixanol 320 Urine NGAL | 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. | 2 hours post-dose | -29.51 ng/mL | Standard Deviation 55.67 |
| Iodixanol 320 Urine NGAL | 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. | 48 hours post-dose | 30.09 ng/mL | Standard Deviation 106.75 |
| Iodixanol 320 Urine NGAL | 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. | 6 hours post-dose | -51.00 ng/mL | Standard Deviation 65.46 |
| Iodixanol 320 Urine NGAL | 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. | 72 hours post-dose | NA ng/mL | — |