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

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ClinicalTrials.gov Identifier: NCT01255722
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : December 16, 2015
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: iobitridol Drug: iopromide Drug: iomeprol Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
Study Start Date : November 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Iopromide

Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment [ Time Frame: < 24h ]

    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 :
  1. Average Image Quality According to Off-site Reading [ Time Frame: <24h ]
    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).

  2. Coronary Track Rate [ Time Frame: <24h ]
    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.

  3. Average Signal Attenuation After IV Injection of Contrast [ Time Frame: <1h ]
    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.

  4. Average Signal-to-Noise Ratio (Average SNR) [ Time Frame: <1h ]

    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


  5. Average Contrast-to-noise Ratio (Average CNR) [ Time Frame: <1h ]

    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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255722


Locations
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Sponsors and Collaborators
Guerbet
Investigators
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Principal Investigator: Martin HOFFMANN, MD Kantonsspital Lucerne- Switzerland
More Information
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01255722    
Other Study ID Numbers: ISO-44-012
First Posted: December 7, 2010    Key Record Dates
Results First Posted: December 16, 2015
Last Update Posted: December 16, 2015
Last Verified: November 2015
Keywords provided by Guerbet:
iodinated contrast media, coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases