Trial Outcomes & Findings for Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA) (NCT NCT02171247)
NCT ID: NCT02171247
Last Updated: 2014-08-15
Results Overview
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
COMPLETED
PHASE3
35 participants
during scan, approximately 3 hours
2014-08-15
Participant Flow
35 subjects signed consent. 2 subjects were not assigned to a arm and were withdrawn from study due to impaired renal function. 33 subjects completed the study.
Participant milestones
| Measure |
Visipaque 320
Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol.
|
Isovue 370
Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Baseline characteristics by cohort
| Measure |
Visipaque 320
n=16 Participants
Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol.
|
Isovue 370
n=17 Participants
Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years and older
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during scan, approximately 3 hoursContrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Outcome measures
| Measure |
Visipaque 320
n=16 Participants
Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol.
|
Isovue 370
n=17 Participants
Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
|
|---|---|---|
|
Contrast to Noise Ratio
|
18.6 CNR
Standard Deviation 5.2
|
20.5 CNR
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: during scan, approximately 3 hoursDepiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
Outcome measures
| Measure |
Visipaque 320
n=16 Participants
Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol.
|
Isovue 370
n=17 Participants
Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
|
|---|---|---|
|
Image Quality
Conus
|
43.8 % of coronary branches visualized
|
94.1 % of coronary branches visualized
|
|
Image Quality
Sinoatrial Nodal
|
37.5 % of coronary branches visualized
|
82.4 % of coronary branches visualized
|
|
Image Quality
Diagonal1
|
87.5 % of coronary branches visualized
|
35.3 % of coronary branches visualized
|
|
Image Quality
Diagonal1 and Diagonal2
|
12.5 % of coronary branches visualized
|
64.7 % of coronary branches visualized
|
|
Image Quality
Obutse Marginal1
|
68.8 % of coronary branches visualized
|
29.4 % of coronary branches visualized
|
|
Image Quality
Obutse Marginal1 and Obutse Marginal2
|
6.3 % of coronary branches visualized
|
70.6 % of coronary branches visualized
|
|
Image Quality
Acute marginal1
|
62.5 % of coronary branches visualized
|
47.1 % of coronary branches visualized
|
|
Image Quality
Acute marginal1 and Acute marginal2
|
18.8 % of coronary branches visualized
|
52.9 % of coronary branches visualized
|
|
Image Quality
Septal perforator
|
43.8 % of coronary branches visualized
|
88.2 % of coronary branches visualized
|
|
Image Quality
Posterolateral
|
6.3 % of coronary branches visualized
|
64.7 % of coronary branches visualized
|
PRIMARY outcome
Timeframe: during scan, approximately 3 hoursPopulation: Data was not collected and therefore not analysed
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: during scan, approximately 3 hoursThe 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.
Outcome measures
| Measure |
Visipaque 320
n=16 Participants
Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol.
|
Isovue 370
n=17 Participants
Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
|
|---|---|---|
|
Attenuation of the Ascending Aorta and Coronary Arteries
ascending aorta
|
19.5 CNR
Standard Deviation 4.8
|
21.6 CNR
Standard Deviation 4.2
|
|
Attenuation of the Ascending Aorta and Coronary Arteries
coronary arteries
|
18.4 CNR
Standard Deviation 5.3
|
20.3 CNR
Standard Deviation 4.6
|
Adverse Events
Visipaque 320
Isovue 370
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place