Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography

Coronary Artery Disease Clinical Trial

— X-ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255722
• Other study ID #: ISO-44-012
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2010
• Last updated: November 12, 2015
• Start date: November 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2015
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthSpain: Ministry of HealthSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• iobitridol
single IV injection
• iopromide
Single IV injection
• iomeprol
Single IV injection

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU de la Cavale Blanche	Brest
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson
France	La Timone Adultes	Marseille
France	Hopital Cochin	Paris
France	Haut-Lévêque / Radiologie	Pessac
France	CHU Pontchaillou	Rennes
France	CHU Rouen - Hopital Charles Nicolle	Rouen
France	Centre Cardiologique du Nord	Saint Denis
Germany	Institut für Radiologie Universitätsklinikum Charité	Berlin
Germany	University Hospital Erlangen	Erlangen
Germany	Elisabeth-Krankenhaus Hospital	Essen
Germany	University Hospital Mannheim	Mannheim
Germany	University Hospital LMU	Munich
Germany	Universitätsklinik Ulm	Ulm
Italy	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
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela
Switzerland	Institut für Radiologie	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	< 24h	No
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).	<24h	No
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.	<24h	No
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.	<1h	No
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	<1h	No
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	<1h	No