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slow enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOPAMIDOL injection 370 | Active Comparator |
| |
| Iodixanol 320 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopamidol 370 | Drug | one time administration for PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2,4,6,24, 48, and 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institu De Cardiologie De Montreal | Montreal | Quebec | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iopamidol 370 | Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure |
| FG001 | Iodixanol 320 | Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| 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 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 2,4,6,24, 48, and 72 hours post-dose |
|
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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 | Iopamidol 370 | Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: 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 |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Iodixanol 320 | Drug | Iodixanol 320 single injection for percutaneous coronary injection |
|
| 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. |
| 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 |
|
| OG002 | Iodixanol 320 Serum NGAL | Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320 |
| OG003 | Iodixanol 320 Urine NGAL | Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320 |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Iodixanol 320 | Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure | 0 | 7 | 0 | 7 |
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| D014652 |
| Vascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |