Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT)

Guerbet

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: iopromide; Drug: iobitridol; Drug: iomeprol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01255722

ISO-44-012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adult patient (having reached legal majority age)
• Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 3 patient groups

Iobitridol

Experimental group

Description:

Patients were IV injected with a single dose of iobitridol before a coronary CT angiography

Treatment:

Drug: iobitridol

Iopromide

Active Comparator group

Description:

Patients were IV injected with a single dose of iopromide before a coronary CT angiography

Treatment:

Drug: iopromide

Iomeprol

Active Comparator group

Description:

Patients were IV injected with a single dose of iomeprol before a coronary CT angiography

Treatment:

Drug: iomeprol