Clinical trial NCT01255722: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
Official title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: iodinated contrast media, coronary artery disease
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment
timeFrame: < 24h
Secondary outcomes:
measure: Average Image Quality According to Off-site Reading
timeFrame: <24h
measure: Coronary Track Rate
timeFrame: <24h
measure: Average Signal Attenuation After IV Injection of Contrast
timeFrame: <1h
measure: Average Signal-to-Noise Ratio (Average SNR)
timeFrame: <1h
measure: Average Contrast-to-noise Ratio (Average CNR)
timeFrame: <1h
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Marseille
country: France
facility: La Timone Adultes
city: Paris
country: France
facility: Hopital Cochin
city: Pessac
country: France
facility: Haut-Lévêque / Radiologie
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU Rouen - Hopital Charles Nicolle
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Berlin
country: Germany
facility: Institut für Radiologie Universitätsklinikum Charité
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Hospital
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Munich
country: Germany
facility: University Hospital LMU
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
city: Brindisi
country: Italy
facility: Ospedale A.Perrino U.O. di radiodiagnostica
city: Ferrara
country: Italy
facility: Ospedale del Delta
city: Rome
country: Italy
facility: Sapienza-universita di Roma
city: Verona
country: Italy
facility: Ospedale civile Maggiore du Verona Borgo
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: St. Gallen
country: Switzerland
facility: Institut für Radiologie
Study officials:
affiliation: Kantonsspital Lucerne- Switzerland
name: Martin HOFFMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: