Coronary Computed Tomographic Angiography
Conditions
Keywords
coronary computed tomographic angiography, contrast
Brief summary
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.
Interventions
DRUGIsovue 370
Isovue 370 is a contrast agent with increased iodine concentration.
DRUGVisipaque 320
Visipaque 320 is standard protocol.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients who are referred for coronary CTA for suspected or known coronary artery disease
Exclusion criteria
* creatinine greater than 2.0 * allergy to contrast media * patients under the age of 18 * women who are pregnant or breast feeding * patients with cardiac arrhythmia will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast to Noise Ratio | during scan, approximately 3 hours | Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation. |
| Image Quality | during scan, approximately 3 hours | Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels. |
| Motion Artifact | during scan, approximately 3 hours | The outcome will be measured by individual scores. The scores from multiple readers will be averaged. |
| Attenuation of the Ascending Aorta and Coronary Arteries | during scan, approximately 3 hours | 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. |
Participant flow
Recruitment details
35 subjects signed consent. 2 subjects were not assigned to a arm and were withdrawn from study due to impaired renal function. 33 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Visipaque 320 Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol. | 16 |
| Isovue 370 Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration. | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Visipaque 320 | Isovue 370 | Total |
|---|---|---|---|
| Age, Customized 18 years and older | 16 participants | 17 participants | 33 participants |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
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.
Time frame: during scan, approximately 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Visipaque 320 | Attenuation of the Ascending Aorta and Coronary Arteries | ascending aorta | 19.5 CNR | Standard Deviation 4.8 |
| Visipaque 320 | Attenuation of the Ascending Aorta and Coronary Arteries | coronary arteries | 18.4 CNR | Standard Deviation 5.3 |
| Isovue 370 | Attenuation of the Ascending Aorta and Coronary Arteries | ascending aorta | 21.6 CNR | Standard Deviation 4.2 |
| Isovue 370 | Attenuation of the Ascending Aorta and Coronary Arteries | coronary arteries | 20.3 CNR | Standard Deviation 4.6 |
Primary
Contrast to Noise Ratio
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Time frame: during scan, approximately 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visipaque 320 | Contrast to Noise Ratio | 18.6 CNR | Standard Deviation 5.2 |
| Isovue 370 | Contrast to Noise Ratio | 20.5 CNR | Standard Deviation 4.5 |
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.
Time frame: during scan, approximately 3 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visipaque 320 | Image Quality | Conus | 43.8 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Sinoatrial Nodal | 37.5 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Diagonal1 | 87.5 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Diagonal1 and Diagonal2 | 12.5 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Obutse Marginal1 | 68.8 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Obutse Marginal1 and Obutse Marginal2 | 6.3 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Acute marginal1 | 62.5 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Acute marginal1 and Acute marginal2 | 18.8 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Septal perforator | 43.8 % of coronary branches visualized |
| Visipaque 320 | Image Quality | Posterolateral | 6.3 % of coronary branches visualized |
| Isovue 370 | Image Quality | Acute marginal1 and Acute marginal2 | 52.9 % of coronary branches visualized |
| Isovue 370 | Image Quality | Conus | 94.1 % of coronary branches visualized |
| Isovue 370 | Image Quality | Obutse Marginal1 and Obutse Marginal2 | 70.6 % of coronary branches visualized |
| Isovue 370 | Image Quality | Sinoatrial Nodal | 82.4 % of coronary branches visualized |
| Isovue 370 | Image Quality | Posterolateral | 64.7 % of coronary branches visualized |
| Isovue 370 | Image Quality | Diagonal1 | 35.3 % of coronary branches visualized |
| Isovue 370 | Image Quality | Acute marginal1 | 47.1 % of coronary branches visualized |
| Isovue 370 | Image Quality | Diagonal1 and Diagonal2 | 64.7 % of coronary branches visualized |
| Isovue 370 | Image Quality | Septal perforator | 88.2 % of coronary branches visualized |
| Isovue 370 | Image Quality | Obutse Marginal1 | 29.4 % of coronary branches visualized |
Primary
Motion Artifact
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Time frame: during scan, approximately 3 hours
Population: Data was not collected and therefore not analysed