Coronary Artery DiseasePhase 4X-ACTNCT01255722

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

A Phase 4 study testing iobitridol, iopromide and iomeprol in people with Coronary Artery Disease, run by Guerbet at 23 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: iobitridol, iopromide and iomeprol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 468 participants
Where: 23 sitesin 5 countries
Study dates: Nov 2010to Sep 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Who cannot join

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

Trial locations and contacts

23 sites in 5 countries.

Country

City, postcode or hospital

23 sites in 5 countries

France9 sites

CHU Angers
Angers, 49033
CHU de la Cavale Blanche
Brest, 29609
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
La Timone Adultes
Marseille, 13385
Hopital Cochin
Paris, 75014
Haut-Lévêque / Radiologie
Pessac, 33604
CHU Pontchaillou
Rennes, 35033
CHU Rouen - Hopital Charles Nicolle
Rouen, 76031
Centre Cardiologique du Nord
Saint-Denis, 93207

Other trials in France

Germany6 sites

Institut für Radiologie Universitätsklinikum Charité
Berlin, 10117
University Hospital Erlangen
Erlangen, 191054
Elisabeth-Krankenhaus Hospital
Essen, 45138
University Hospital Mannheim
Mannheim, 368167
University Hospital LMU
Munich, 81377
Universitätsklinik Ulm
Ulm, 89081

Other trials in Germany

Italy4 sites

Ospedale A.Perrino U.O. di radiodiagnostica
Brindisi
Ospedale del Delta
Ferrara
Sapienza-universita di Roma
Rome
Ospedale civile Maggiore du Verona Borgo
Verona, 37126

Other trials in Italy

Spain3 sites

Hospital Vall d'Hebron
Barcelona
Hospital Clinico San Carlos
Madrid, 28040
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela

Other trials in Spain

Switzerland1 site

Institut für Radiologie
Sankt Gallen

Other trials in Switzerland

About this study

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

Read the 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.

Conditions: Coronary Artery Disease
Being tested: iobitridol, iopromide, iomeprol
Keywords: iodinated contrast media, coronary artery disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iobitridolDrug
Also called Xenetix®
single IV injection
iopromideDrug
Also called Ultravist®
Single IV injection
iomeprolDrug
Also called Iomeron®
Single IV injection

Study groups in NCT01255722
Study group	Role	What they receive
Iobitridol	Experimental	Patients were IV injected with a single dose of iobitridol before a coronary CT angiography Receives: Drug: iobitridol
Iopromide	Active comparator	Patients were IV injected with a single dose of iopromide before a coronary CT angiography Receives: Drug: iopromide
Iomeprol	Active comparator	Patients were IV injected with a single dose of iomeprol before a coronary CT angiography Receives: Drug: iomeprol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: < 24h

Secondary outcomes (5)

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).
Measured: <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.
Measured: <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.
Measured: <1h
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
Measured: <1h
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
Measured: <1h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Sep 2012

First posted7 Dec 2010 (estimated)
Study startNov 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 468 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01255722
Sponsor's protocol ID: ISO-44-012
Acronym: X-ACT
Status last verified: Nov 2015
First submitted: 3 Dec 2010
Last updated: 16 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
ClinicalTrials.gov ID: NCT01255722
Acronym / sponsor ID: X-ACT / ISO-44-012
Conditions: Coronary Artery Disease
Keywords: iodinated contrast media, coronary artery disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 468 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 7 Dec 2010 (estimated)
Results: Posted 16 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Iobitridol	Experimental	Drug: iobitridolPatients were IV injected with a single dose of iobitridol before a coronary CT angiography
Iopromide	Active comparator	Drug: iopromidePatients were IV injected with a single dose of iopromide before a coronary CT angiography
Iomeprol	Active comparator	Drug: iomeprolPatients were IV injected with a single dose of iomeprol before a coronary CT angiography

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iobitridolAlso: Xenetix®single IV injection	Drug	Iobitridol
iopromideAlso: Ultravist®Single IV injection	Drug	Iopromide
iomeprolAlso: Iomeron®Single IV injection	Drug	Iomeprol

Primary outcome

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.

5 secondary outcomes

Average Image Quality According to Off-site Reading
Time frame: <24h
Coronary Track Rate
Time frame: <24h
Average Signal Attenuation After IV Injection of Contrast
Time frame: <1h
Average Signal-to-Noise Ratio (Average SNR)
Time frame: <1h
Average Contrast-to-noise Ratio (Average CNR)
Time frame: <1h

Results and safety

Results posted to the registry on 16 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iobitridol	155	152
Iopromide	160	159
Iomeprol	153	152

Primary outcome: Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment

Time frame: < 24h. Geometric mean (Standard Error). Unit: Percentage of patients

Measure	Iobitridol n = 151	Iopromide n = 152	Iomeprol n = 149
Value	92.1 (2.2)	95.4 (1.7)	94.6 (1.8)

Iobitridol vs Iopromide vs Iomeprol: Mean Difference (Final Values): -0.033 (95% CI -0.088 to 0.021), p = 0.05, Chi-squared

Population analysed: Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iobitridol	0 of 152 (0%)	23 of 152 (15.1%)	Not reported
Iopromide	0 of 159 (0%)	31 of 159 (19.5%)	Not reported
Iomeprol	1 of 152 (0.7%)	23 of 152 (15.1%)	Not reported

Limitations and caveats (from the sponsor): The main limitation of the study is the absence of gold standard such as conventional angiography to confirm the readers' assessments. Diagnostic accuracy could therefore not be compared.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin HOFFMANN, MD principal investigator

Kantonsspital Lucerne- Switzerland

23 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iobitridol, iopromide and iomeprol in people with Coronary Artery Disease, run by Guerbet at 23 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Germany, Italy, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment (time frame: < 24h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01255722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.