Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT01255722
- Lead Sponsor
- Guerbet
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
- Male or female adult patient (having reached legal majority age)
- Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography
- Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
- Patient with arrhythmia or non-sinus rhythm
- Patient with decompensated heart failure
- Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
- Patient who has previously undergone coronary artery bypass graft
- Patient who has previously undergone percutaneous transluminal coronary stent placement
- Patient with artificial heart valve
- Patient with known moderate to severe aortic stenosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iobitridol iobitridol Patients were IV injected with a single dose of iobitridol before a coronary CT angiography Iopromide iopromide Patients were IV injected with a single dose of iopromide before a coronary CT angiography Iomeprol iomeprol Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
- Primary Outcome Measures
Name Time Method Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment < 24h 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.
- Secondary Outcome Measures
Name Time Method Coronary Track Rate <24h 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.
Average Signal Attenuation After IV Injection of Contrast <1h 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.
Average Signal-to-Noise Ratio (Average SNR) <1h 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 NoiseAverage Image Quality According to Off-site Reading <24h 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).
Average Contrast-to-noise Ratio (Average CNR) <1h 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
Trial Locations
- Locations (23)
CHU Rouen - Hopital Charles Nicolle
🇫🇷Rouen, France
La Timone Adultes
🇫🇷Marseille, France
Centre Chirurgical Marie Lannelongue
🇫🇷Le Plessis Robinson, France
CHU Angers
🇫🇷Angers, France
CHU de la Cavale Blanche
🇫🇷Brest, France
Hopital Cochin
🇫🇷Paris, France
Haut-Lévêque / Radiologie
🇫🇷Pessac, France
CHU Pontchaillou
🇫🇷Rennes, France
Centre Cardiologique du Nord
🇫🇷Saint Denis, France
Institut für Radiologie Universitätsklinikum Charité
🇩🇪Berlin, Germany
University Hospital Erlangen
🇩🇪Erlangen, Germany
University Hospital LMU
🇩🇪Munich, Germany
University Hospital Mannheim
🇩🇪Mannheim, Germany
Universitätsklinik Ulm
🇩🇪Ulm, Germany
Sapienza-universita di Roma
🇮🇹Rome, Italy
Elisabeth-Krankenhaus Hospital
🇩🇪Essen, Germany
Ospedale A.Perrino U.O. di radiodiagnostica
🇮🇹Brindisi, Italy
Ospedale del Delta
🇮🇹Ferrara, Italy
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Ospedale civile Maggiore du Verona Borgo
🇮🇹Verona, Italy
Institut für Radiologie
🇨🇭St. Gallen, Switzerland
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain