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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOPAMIDOL 370 | Active Comparator |
| |
| IODIXANOL 320 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non ionic contrast media comparator | 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. | 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. | 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 |
|---|---|---|---|---|---|---|
| Prairie Cardiovascular Consultants, Ltd. | Springfield | Illinois | 62701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodixanol 320 | Non ionic contrast media comparator : one time administration for PCI |
| FG001 | Iopamidol 370 | Non ionic contrast media comparator : one time administration for PCI |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Evaluable patient population for NGAL analysis included all patients with both pre-dose baseline and post-dose blood and/or urine NGAL values for at least 2 out of the 4 planned measurements within 24 hours post-administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodixanol 320 NGAL Evaluable Population | Non-ionic contrast media comparator: one time administration for PCI |
| BG001 | Iopamidol 370 NGAL Evaluable Population | Non-ionic contrast media comparator: one time administration for PCI |
| 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. | 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. | 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 | Iodixanol 320 | Non ionic contrast media comparator : one time administration for PCI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Fibrillation | Cardiac disorders |
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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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| Non ionic contrast media comparator | Drug | one time administration for PCI |
|
|
| 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 | 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. |
|
|
| 1 |
| 25 |
| 0 |
| 25 |
| EG001 | Iopamidol 370 | Non ionic contrast media comparator : One time administration for PCI | 0 | 24 | 0 | 24 |
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| D014652 |
| Vascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |