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

Guerbet468 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

468

Conditions

Coronary Artery Disease

Interventions

iobitridolDRUG

single IV injection

iopromideDRUG

Single IV injection

iomeprolDRUG

Single IV injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

CHU Angers

Angers, France

CHU de la Cavale Blanche

Brest, France

Outcomes

Primary Outcomes

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.

Time frame: < 24h

Secondary Outcomes

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).

Time frame: <24h

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.

Time frame: <24h

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.

Time frame: <1h

Average Signal-to-Noise Ratio (Average SNR)

Data from ClinicalTrials.gov

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