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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-volume contrast media injection protocol | Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultravist 370Mg I/Ml Solution for Injection | Drug | Reduced contrast-volume injection protocols based on patient specific tube voltage. |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative assessment of image quality | This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups. | 2 years |
| Quantitative assessment of image quality | Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose of coronary CTA | Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
Subject has an acute psychiatric disorder.
Subject is unwilling to comply with the requirements of the protocol.
Subject has previously entered this study.
Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
Subject has impaired renal function (creatinine > 1.5 mg/dl).
Subject is in unstable condition.
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The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C038192 | iopromide |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |