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Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isovue 370 | Active Comparator | Isovue 370 is a contrast agent with increased iodine concentration. |
|
| Visipaque 320 | Active Comparator | Standard protocol is Visipaque 320. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isovue 370 | Drug | Isovue 370 is a contrast agent with increased iodine concentration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast to Noise Ratio | Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation. | during scan, approximately 3 hours |
| Image Quality | Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels. | during scan, approximately 3 hours |
| Motion Artifact | The outcome will be measured by individual scores. The scores from multiple readers will be averaged. | during scan, approximately 3 hours |
| Attenuation of the Ascending Aorta and Coronary Arteries | The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments. | during scan, approximately 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T Boll, MD | Duke University | Principal Investigator |
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35 subjects signed consent. 2 subjects were not assigned to a arm and were withdrawn from study due to impaired renal function. 33 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Visipaque 320 | Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol. |
| FG001 | Isovue 370 | Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visipaque 320 | Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol. |
| BG001 | Isovue 370 | Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Contrast to Noise Ratio | Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation. | Posted | Mean | Standard Deviation | CNR | during scan, approximately 3 hours |
|
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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 | Visipaque 320 | Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel T Boll, MD | Duke University Medical Center | 919-684-2711 | daniel.boll@duke.edu |
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| ID | Term |
|---|---|
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Visipaque 320 |
| Drug |
Visipaque 320 is standard protocol. |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Image Quality | Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels. | Posted | Number | % of coronary branches visualized | during scan, approximately 3 hours |
|
|
|
| Primary | Motion Artifact | The outcome will be measured by individual scores. The scores from multiple readers will be averaged. | Data was not collected and therefore not analysed | Posted | during scan, approximately 3 hours |
|
|
| Primary | Attenuation of the Ascending Aorta and Coronary Arteries | The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments. | Posted | Mean | Standard Deviation | CNR | during scan, approximately 3 hours |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Isovue 370 | Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration. | 0 | 17 | 0 | 17 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Diagonal1 |
|
| Diagonal1 and Diagonal2 |
|
| Obutse Marginal1 |
|
| Obutse Marginal1 and Obutse Marginal2 |
|
| Acute marginal1 |
|
| Acute marginal1 and Acute marginal2 |
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| Septal perforator |
|
| Posterolateral |
|