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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ioxaglate Arm | Experimental |
| |
| Iodixanol arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol | Drug | contrast media used during coronary angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin Generation Test: Baseline | The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. | baseline |
| Thrombin Generation Test: After Coronary Angiography | The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Maximal Platelet Aggregation: Epinephrine | Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine | Baseline to 1 hour |
| Percent Change in Maximal Platelet Aggregation: Arachidonic Acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Feit, MD | NYU Langone Health | Principal Investigator |
| Binita Shah, MD, MS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ioxaglate Arm | Ioxaglate: contrast media used during coronary angiography |
| FG001 | Iodixanol Arm | Iodixanol: contrast media used during coronary angiography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ioxaglate Arm | Ioxaglate: contrast media used during coronary angiography |
| BG001 | Iodixanol Arm | Iodixanol: contrast media used during coronary angiography |
| 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 | Thrombin Generation Test: Baseline | The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. | A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis. | Posted | Median | Inter-Quartile Range | nM*minutes | baseline |
|
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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 | Ioxaglate Arm | Ioxaglate: contrast media used during coronary angiography |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hives/rash | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Binita Shah | NYU Langone Medical Center | 212-263-4235 | binita.shah@nyumc.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
| D007485 | Ioxaglic Acid |
| C074619 | bivalirudin |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Ioxaglate | Drug | contrast media used during coronary angiography |
|
|
| Bivalirudin | Drug | A direct thrombin inhibitor |
|
|
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid |
| 1 hour |
| Percent Change in Maximal Platelet Aggregation: ADP | Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP | 1 hour |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Iodixanol Arm |
Iodixanol: contrast media used during coronary angiography |
|
|
| Secondary | Percent Change in Maximal Platelet Aggregation: Epinephrine | Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine | Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure. | Posted | Median | Inter-Quartile Range | Percent change | Baseline to 1 hour |
|
|
|
| Secondary | Percent Change in Maximal Platelet Aggregation: Arachidonic Acid | Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid | Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure. | Posted | Median | Inter-Quartile Range | Percent change | 1 hour |
|
|
|
| Secondary | Percent Change in Maximal Platelet Aggregation: ADP | Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP | Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure. | Posted | Median | Inter-Quartile Range | Percent change | 1 hour |
|
|
|
| Primary | Thrombin Generation Test: After Coronary Angiography | The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. | A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis. | Posted | Median | Inter-Quartile Range | nM*minutes | 1 hour |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| EG001 | Iodixanol Arm | Iodixanol: contrast media used during coronary angiography | 0 | 50 | 1 | 50 |
| Nausea | Gastrointestinal disorders |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |