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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
iobitridol
iopromide
iomeprol
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring iodinated contrast media, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Angers
  • CHU de la Cavale Blanche
  • Centre Chirurgical Marie Lannelongue
  • La Timone Adultes
  • Hopital Cochin
  • Haut-Lévêque / Radiologie
  • CHU Pontchaillou
  • CHU Rouen - Hopital Charles Nicolle
  • Centre Cardiologique du Nord
  • Institut für Radiologie Universitätsklinikum Charité
  • University Hospital Erlangen
  • Elisabeth-Krankenhaus Hospital
  • University Hospital Mannheim
  • University Hospital LMU
  • Universitätsklinik Ulm
  • Ospedale A.Perrino U.O. di radiodiagnostica
  • Ospedale del Delta
  • Sapienza-universita di Roma
  • Ospedale civile Maggiore du Verona Borgo
  • Hospital Vall d'Hebron
  • Hospital Clinico San Carlos
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • Institut für Radiologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Iobitridol

Iopromide

Iomeprol

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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
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

Full Information

First Posted
December 3, 2010
Last Updated
November 12, 2015
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT01255722
Brief Title
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
Acronym
X-ACT
Official Title
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
iodinated contrast media, coronary artery disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iobitridol
Arm Type
Experimental
Arm Description
Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
Arm Title
Iopromide
Arm Type
Active Comparator
Arm Description
Patients were IV injected with a single dose of iopromide before a coronary CT angiography
Arm Title
Iomeprol
Arm Type
Active Comparator
Arm Description
Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Intervention Type
Drug
Intervention Name(s)
iobitridol
Other Intervention Name(s)
Xenetix®
Intervention Description
single IV injection
Intervention Type
Drug
Intervention Name(s)
iopromide
Other Intervention Name(s)
Ultravist®
Intervention Description
Single IV injection
Intervention Type
Drug
Intervention Name(s)
iomeprol
Other Intervention Name(s)
Iomeron®
Intervention Description
Single IV injection
Primary Outcome Measure Information:
Title
Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment
Description
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 Outcome Measure Information:
Title
Average Image Quality According to Off-site Reading
Description
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
Title
Coronary Track Rate
Description
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
Title
Average Signal Attenuation After IV Injection of Contrast
Description
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
Title
Average Signal-to-Noise Ratio (Average SNR)
Description
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
Time Frame
<1h
Title
Average Contrast-to-noise Ratio (Average CNR)
Description
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
Time Frame
<1h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin HOFFMANN, MD
Organizational Affiliation
Kantonsspital Lucerne- Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CHU de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Facility Name
La Timone Adultes
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Haut-Lévêque / Radiologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Rouen - Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
ZIP/Postal Code
93207
Country
France
Facility Name
Institut für Radiologie Universitätsklinikum Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
191054
Country
Germany
Facility Name
Elisabeth-Krankenhaus Hospital
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
368167
Country
Germany
Facility Name
University Hospital LMU
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Ospedale A.Perrino U.O. di radiodiagnostica
City
Brindisi
Country
Italy
Facility Name
Ospedale del Delta
City
Ferrara
Country
Italy
Facility Name
Sapienza-universita di Roma
City
Rome
Country
Italy
Facility Name
Ospedale civile Maggiore du Verona Borgo
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Institut für Radiologie
City
St. Gallen
Country
Switzerland

12. IPD Sharing Statement

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

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