- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255722
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT)
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49033
- CHU Angers
-
Brest, France, 29609
- CHU de la Cavale Blanche
-
Le Plessis Robinson, France, 92350
- Centre Chirurgical Marie Lannelongue
-
Marseille, France, 13385
- La Timone Adultes
-
Paris, France, 75014
- Hopital Cochin
-
Pessac, France, 33604
- Haut-Lévêque / Radiologie
-
Rennes, France, 35033
- CHU Pontchaillou
-
Rouen, France, 76031
- CHU Rouen - Hôpital Charles Nicolle
-
Saint Denis, France, 93207
- Centre Cardiologique du Nord
-
-
-
-
-
Berlin, Germany, 10117
- Institut für Radiologie Universitätsklinikum Charité
-
Erlangen, Germany, 191054
- University Hospital Erlangen
-
Essen, Germany, 45138
- Elisabeth-Krankenhaus Hospital
-
Mannheim, Germany, 368167
- University Hospital Mannheim
-
Munich, Germany, 81377
- University Hospital LMU
-
Ulm, Germany, 89081
- Universitätsklinik Ulm
-
-
-
-
-
Brindisi, Italy
- Ospedale A.Perrino U.O. di radiodiagnostica
-
Ferrara, Italy
- Ospedale del Delta
-
Rome, Italy
- Sapienza-universita di Roma
-
Verona, Italy, 37126
- Ospedale civile Maggiore du Verona Borgo
-
-
-
-
-
Barcelona, Spain
- Hospital Vall d'Hebron
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos
-
Santiago de Compostela, Spain
- Complejo Hospitalario Universitario De Santiago De Compostela
-
-
-
-
-
St. Gallen, Switzerland
- Institut für Radiologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iobitridol
Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
|
single IV injection
Other Names:
|
Active Comparator: Iopromide
Patients were IV injected with a single dose of iopromide before a coronary CT angiography
|
Single IV injection
Other Names:
|
Active Comparator: Iomeprol
Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
|
Single IV injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
< 24h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
<24h
|
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.
|
<24h
|
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.
|
<1h
|
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 |
<1h
|
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 |
<1h
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin HOFFMANN, MD, Kantonsspital Lucerne- Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISO-44-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on iobitridol
-
GuerbetCompletedDiagnostic ImagingAustria, France
-
Azienda Sanitaria Locale 9, GrossetoCompletedContrast Induced Acute Kidney InjuryItaly
-
GuerbetCompletedType 2 Diabetes Mellitus | Coronary AtherosclerosisKorea, Republic of