Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
Computed Tomography
Brief summary
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).
Interventions
DRUGUltravist 370Mg I/Ml Solution for Injection
Reduced contrast-volume injection protocols based on patient specific tube voltage.
Sponsors
Bayer
Medical University of South Carolina
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Referred for a clinically indicated CCTA scan. 2. Subject must be 18 - 85 years of age. 3. Subject must provide written informed consent prior to any study-related procedures being performed. 4. Subject must be willing to comply with all clinical study procedures.
Exclusion criteria
1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy: * By testing (serum or urine beta HCG) within 24 hours before study agent administration, or * By surgical sterilization, or * Post-menopausal, with minimum one (1) year history without menses. 2. 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. 3. 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). 4. Subject has an acute psychiatric disorder. 5. Subject is unwilling to comply with the requirements of the protocol. 6. Subject has previously entered this study. 7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study. 8. Subject has impaired renal function (creatinine \> 1.5 mg/dl). 9. Subject is in unstable condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment of image quality | 2 years | 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. |
| Quantitative assessment of image quality | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose of coronary CTA | 2 years | Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols. |
Countries
United States
Outcome results
None listed