Conditions: Coronary Artery Disease
Keywords: iodinated contrast media, coronary artery disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 468
Healthy volunteers: no

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.

Arms:
arm 1: Patients were IV injected with a single dose of iobitridol before a coronary CT angiography arm 2: Patients were IV injected with a single dose of iopromide before a coronary CT angiography arm 3: Patients were IV injected with a single dose of iomeprol before a coronary CT angiography

Interventions: intervention 1: iobitridol intervention 2: iopromide intervention 3: iomeprol
Intervention descriptions: intervention 1: single IV injection intervention 2: Single IV injection intervention 3: Single IV injection

Protocol document: