Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iobitridol | Experimental | Patients were IV injected with a single dose of iobitridol before a coronary CT angiography |
|
| Iopromide | Active Comparator | Patients were IV injected with a single dose of iopromide before a coronary CT angiography |
|
| Iomeprol | Active Comparator | Patients were IV injected with a single dose of iomeprol before a coronary CT angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iobitridol | Drug | single IV injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | < 24h |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | <24h |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin HOFFMANN, MD | Kantonsspital Lucerne- Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49033 | France | |||
| CHU de la Cavale Blanche |
Not provided
A total of 468 patients from 5 European countries were enrolled and evaluated between 3 November 2010 and 17 September 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Iobitridol | Patients were IV injected with a single dose of iobitridol before a coronary CT angiography |
| FG001 | Iopromide | Patients were IV injected with a single dose of iopromide before a coronary CT angiography |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| iopromide | Drug | Single IV injection |
|
|
| iomeprol | Drug | Single IV injection |
|
|
| 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. | <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. | <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 | <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 | <1h |
| Brest |
| 29609 |
| France |
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| La Timone Adultes | Marseille | 13385 | France |
| Hopital Cochin | Paris | 75014 | France |
| Haut-Lévêque / Radiologie | Pessac | 33604 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| CHU Rouen - Hopital Charles Nicolle | Rouen | 76031 | France |
| Centre Cardiologique du Nord | Saint-Denis | 93207 | France |
| Institut für Radiologie Universitätsklinikum Charité | Berlin | 10117 | Germany |
| University Hospital Erlangen | Erlangen | 191054 | Germany |
| Elisabeth-Krankenhaus Hospital | Essen | 45138 | Germany |
| University Hospital Mannheim | Mannheim | 368167 | Germany |
| University Hospital LMU | Munich | 81377 | Germany |
| Universitätsklinik Ulm | Ulm | 89081 | Germany |
| Ospedale A.Perrino U.O. di radiodiagnostica | Brindisi | Italy |
| Ospedale del Delta | Ferrara | Italy |
| Sapienza-universita di Roma | Rome | Italy |
| Ospedale civile Maggiore du Verona Borgo | Verona | 37126 | Italy |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | Spain |
| Institut für Radiologie | Sankt Gallen | Switzerland |
| FG002 | Iomeprol | Patients were IV injected with a single dose of iomeprol before a coronary CT angiography |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All included patients set: all included patients, even those who have withdrew prior to contrast injection.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iobitridol | Patients were IV injected with a single dose of iobitridol before a coronary CT angiography |
| BG001 | Iopromide | Patients were IV injected with a single dose of iopromide before a coronary CT angiography |
| BG002 | Iomeprol | Patients were IV injected with a single dose of iomeprol before a coronary CT angiography |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint. | Posted | Geometric Mean | Standard Error | Percentage of patients | < 24h |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint. | Posted | Mean | Standard Deviation | Image quality Score on a scale | <24h |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint. | Posted | Mean | Standard Deviation | Number of tracked segments per patient | <24h |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint. | Posted | Geometric Mean | Standard Deviation | Hounsfield Units | <1h |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint. | Posted | Mean | Standard Deviation | Hounsfield Units:Hounsfield Units | <1h |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint. | Posted | Mean | Standard Deviation | Hounsfield Units:Hounsfield Units | <1h |
|
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.
The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iobitridol | Patients were IV injected with a single dose of iobitridol before a coronary CT angiography iobitridol: single IV injection | 0 | 152 | 23 | 152 | ||
| EG001 | Iopromide | Patients were IV injected with a single dose of iopromide before a coronary CT angiography iopromide: Single IV injection | 0 | 159 | 31 | 159 | ||
| EG002 | Iomeprol | Patients were IV injected with a single dose of iomeprol before a coronary CT angiography iomeprol: Single IV injection | 1 | 152 | 23 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Injection Site Pain | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arrythmia | Cardiac disorders | Systematic Assessment |
| ||
| Feeling hot | General disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
The main limitation of the study is the absence of gold standard such as conventional angiography to confirm the readers' assessments. Diagnostic accuracy could therefore not be compared.
No unpublished data given to the investigator may be transmitted to a third party without prior approval of the sponsor in writing. The data are the exclusive property of Guerbet.
The investigator undertakes to submit to Guerbet any draft articles or papers related to this study within 30 days of their submission to the scientific review or the congress scientific committee.
All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Martin HOFFMANN | Section Head Interventional and Cardiac Radiology - Kantonsspital Lucerne, Spitalstrasse, 6006 Lucerne, Switzerland | +41 41 205 4660 | martin.hoffmann@luks.ch |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093233 | iobitridol |
| C038192 | iopromide |
| C057937 | iomeprol |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Spain |
|
| Germany |
|
| Switzerland |
|
| Italy |
|
The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|