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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01255722
First received: December 3, 2010
Last updated: November 12, 2015
Last verified: November 2015
  Purpose
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).

Condition Intervention Phase
Coronary Artery Disease
Drug: iobitridol
Drug: iopromide
Drug: iomeprol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment [ Time Frame: < 24h ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Average Image Quality According to Off-site Reading [ Time Frame: <24h ] [ Designated as safety issue: No ]
    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).

  • Coronary Track Rate [ Time Frame: <24h ] [ Designated as safety issue: No ]
    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.

  • Average Signal Attenuation After IV Injection of Contrast [ Time Frame: <1h ] [ Designated as safety issue: No ]
    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.

  • Average Signal-to-Noise Ratio (Average SNR) [ Time Frame: <1h ] [ Designated as safety issue: No ]

    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


  • Average Contrast-to-noise Ratio (Average CNR) [ Time Frame: <1h ] [ Designated as safety issue: No ]

    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



Enrollment: 468
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iobitridol
Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
Drug: iobitridol
single IV injection
Other Name: Xenetix®
Active Comparator: Iopromide
Patients were IV injected with a single dose of iopromide before a coronary CT angiography
Drug: iopromide
Single IV injection
Other Name: Ultravist®
Active Comparator: Iomeprol
Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Drug: iomeprol
Single IV injection
Other Name: Iomeron®

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255722

Locations
France
CHU Angers
Angers, France, 49033
CHU de la Cavale Blanche
Brest, France, 29609
Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France, 92350
La Timone Adultes
Marseille, France, 13385
Hopital Cochin
Paris, France, 75014
Haut-Lévêque / Radiologie
Pessac, France, 33604
CHU Pontchaillou
Rennes, France, 35033
CHU Rouen - Hopital Charles Nicolle
Rouen, France, 76031
Centre Cardiologique du Nord
Saint Denis, France, 93207
Germany
Institut für Radiologie Universitätsklinikum Charité
Berlin, Germany, 10117
University Hospital Erlangen
Erlangen, Germany, 191054
Elisabeth-Krankenhaus Hospital
Essen, Germany, 45138
University Hospital Mannheim
Mannheim, Germany, 368167
University Hospital LMU
Munich, Germany, 81377
Universitätsklinik Ulm
Ulm, Germany, 89081
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, Italy, 37126
Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain, 28040
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Switzerland
Institut für Radiologie
St. Gallen, Switzerland
Sponsors and Collaborators
Guerbet
Investigators
Principal Investigator: Martin HOFFMANN, MD Kantonsspital Lucerne- Switzerland
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01255722     History of Changes
Other Study ID Numbers: ISO-44-012 
Study First Received: December 3, 2010
Results First Received: August 27, 2015
Last Updated: November 12, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Guerbet:
iodinated contrast media, coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Iobitridol
Iomeprol
Iopromide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2016