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To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iopamidol | Active Comparator | Non-ionic low-osmolar iodinated contrast media |
|
| Iodixanol | Active Comparator | Non-ionic iso-osmolar iodinated contrast media comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopamidol | Drug | Iopamidol 370, one time administration for percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Luigia Storto, MD | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Cooperative, St. John's Hospital | Springfield | Illinois | 62701 | United States | ||
| UMDNJ - RWJ Medical School |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodixanol 320 | Iodixanol 320, a non-ionic iso-osmolar iodinated contrast media comparator, was administered as a single 652 mg dose for percutaneous coronary intervention procedure |
| FG001 | Iopamidol 370 | Iopamidol 370, a non-ionic low-osmolar iodinated contrast media, was administered as a single 755 mg dose for percutaneous coronary intervention procedure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodixanol 320 | Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure |
| BG001 | Iopamidol 370 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose |
|
All adverse events that occurred from the time the patient signed the Informed Consent Form through 2 hours post dose were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodixanol 320 | Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Luigia Storto, M.D. | Bracco Diagnostics Inc. | 609-514-2262 | MariaLuigia.Storto@diag.bracco.com |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007479 | Iopamidol |
| C044834 | iodixanol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Iodixanol-320 | Drug | Iodixanol-320 single administration for percutaneous coronary intervention procedure |
|
|
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| The Institute for Clinical Research at Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Missing NGAL measurement |
|
Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320 |
| OG002 | Iopamidol 370 Serum NGAL | Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370 |
| OG003 | Iopamidol 370 Urine NGAL | Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370 |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Iopamidol 370 | Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention | 0 | 29 | 0 | 29 |
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| D014652 |
| Vascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |