A Phase 4 interventional study of iobitridol and iopromide in Coronary Artery Disease, sponsored by Guerbet. Completed at 23 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-16.
Sponsored by Guerbet · Phase 4, Interventional, and Diagnostic
The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
Patients suspected of coronary artery disease were submitted to coronary CT angiography using either iobitridol or contrast agents with higher iodine concentrations (iopromide or iomeprol). Independent off-site readers evaluated image quality regarding the ability to identify coronary artery stenosis (score 0- non evaluable to 4- excellent quality). The study was aimed at showing the non-inferiority of iobitridol in its ability to provide evaluable CT scans for the identification of coronary stenosis.
5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 468 is above the median of 123 across 3,438 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Guerbet is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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Exclusion Criteria:
Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
Drug: iobitridol
Patients were IV injected with a single dose of iopromide before a coronary CT angiography
Drug: iopromide
Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Drug: iomeprol
single IV injection
Also known as: Xenetix®
Single IV injection
Also known as: Ultravist®
Single IV injection
Also known as: Iomeron®
Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment
Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic. A patient's CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0.
Time frame: < 24h
Average Image Quality According to Off-site Reading
For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).
Time frame: <24h
Coronary Track Rate
A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.
Time frame: <24h
Average Signal Attenuation After IV Injection of Contrast
Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.
Time frame: <1h
Average Signal-to-Noise Ratio (Average SNR)
Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories. A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula: SNR Territory = Post Attenuation / Image Noise
Time frame: <1h
Average Contrast-to-noise Ratio (Average CNR)
Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU). A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att - Baseline Att) / Image Noise
Time frame: <1h
A total of 468 patients from 5 European countries were enrolled and evaluated between 3 November 2010 and 17 September 2012.
| Milestone | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Started | 155 | 160 | 153 |
| Completed | 152 | 159 | 152 |
| Not completed | 3 | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Asymptomatic patient | 1 | 0 | 0 |
| Withdrew: Beta-blocker contraindicated | 2 | 0 | 0 |
Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic. A patient's CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0.
| Percentage of patients | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment | 92.1 ± 2.2 | 95.4 ± 1.7 | 94.6 ± 1.8 |
For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).
| Image quality Score on a scale | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Average Image Quality According to Off-site Reading | 3.5 ± 0.9 | 3.5 ± 0.8 | 3.4 ± 0.9 |
A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.
| Number of tracked segments per patient | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Coronary Track Rate | 10.9 ± 2.2 | 10.8 ± 2.4 | 11.1 ± 2.3 |
Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.
| Hounsfield Units | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Average Signal Attenuation After IV Injection of Contrast | 426.3 ± 92.9 | 449.8 ± 88.1 | 466.4 ± 104.6 |
Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories. A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula: SNR Territory = Post Attenuation / Image Noise
| Hounsfield Units:Hounsfield Units | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Average Signal-to-Noise Ratio (Average SNR) | 16.2 ± 5.6 | 17.1 ± 5.0 | 17.6 ± 6.6 |
Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU). A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att - Baseline Att) / Image Noise
| Hounsfield Units:Hounsfield Units | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Average Contrast-to-noise Ratio (Average CNR) | 14.4 ± 5.4 | 15.3 ± 4.8 | 15.8 ± 6.5 |
Collected over Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iobitridol | — | 0/152 (0%) | 23/152 (15.1%) |
| Iopromide | — | 0/159 (0%) | 31/159 (19.5%) |
| Iomeprol | — | 1/152 (0.7%) | 23/152 (15.1%) |
| Event | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| Rash papularSkin and subcutaneous tissue disorders | 0/152 | 0/159 | 1/152 |
| Event | Iobitridol | Iopromide | Iomeprol |
|---|---|---|---|
| BradycardiaCardiac disorders | 11/152 | 16/159 | 12/152 |
| ExtrasystolesCardiac disorders | 11/152 | 7/159 | 7/152 |
| HeadacheNervous system disorders | 0/152 | 2/159 | 3/152 |
| Injection Site PainGeneral disorders | 0/152 | 3/159 | 2/152 |
| PainGeneral disorders | 2/152 | 0/159 | 0/152 |
| UrticariaSkin and subcutaneous tissue disorders | 0/152 | 2/159 | 0/152 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/152 | 1/159 | 1/152 |
| ArrythmiaCardiac disorders | 1/152 | 0/159 | 0/152 |
| Feeling hotGeneral disorders | 0/152 | 0/159 | 1/152 |
| Rash papularSkin and subcutaneous tissue disorders | 0/152 | 0/159 | 1/152 |
All included patients set: all included patients, even those who have withdrew prior to contrast injection.
| Age, Categorical(Participants) | Iobitridol | Iopromide | Iomeprol | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 104 | 101 | 108 | 313 |
| >=65 years | 51 | 59 | 45 | 155 |
| Age, Continuous(years) | Iobitridol | Iopromide | Iomeprol | Total |
|---|---|---|---|---|
| Mean | 57.9 ± 12.2 | 58.7 ± 11.6 | 56.9 ± 13.4 | 57.8 ± 12.4 |
| Sex: Female, Male(Participants) | Iobitridol | Iopromide | Iomeprol | Total |
|---|---|---|---|---|
| Female | 65 | 68 | 65 | 198 |
| Male | 90 | 92 | 88 | 270 |
| Region of Enrollment(participants) | Iobitridol | Iopromide | Iomeprol | Total |
|---|---|---|---|---|
| France | 59 | 61 | 59 | 179 |
| Spain | 21 | 21 | 20 | 62 |
| Germany | 41 | 45 | 41 | 127 |
| Switzerland | 9 | 9 | 10 | 28 |
| Italy | 25 | 24 | 23 | 72 |
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