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

NCT01255722 | Completed Phase 4 Results DMC

• 1 other identifier: ISO-44-012
• Study Type: interventional
• Target: 468
• Locations: 5 countries
• Sites: 23

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).

Conditions

Coronary Artery Disease

Keywords

iodinated contrast media, coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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.

  < 24h

Secondary Outcomes (5)

• Average Image Quality According to Off-site Reading

  <24h

• Coronary Track Rate

  <24h

• Average Signal Attenuation After IV Injection of Contrast

  <1h

• Average Signal-to-Noise Ratio (Average SNR)

  <1h

• Average Contrast-to-noise Ratio (Average CNR)

  <1h

Study Arms (3)

Iobitridol

EXPERIMENTAL

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

Drug: iobitridol

Iopromide

ACTIVE COMPARATOR

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

Drug: iopromide

Iomeprol

ACTIVE COMPARATOR

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

Drug: iomeprol

Interventions

iobitridol DRUG

single IV injection

Also known as: Xenetix®

Iobitridol

iopromide DRUG

Single IV injection

Also known as: Ultravist®

Iopromide

iomeprol DRUG

Single IV injection

Also known as: Iomeron®

Iomeprol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guerbet: lead

Study Sites (23)

CHU Angers

Angers, 49033, France

Location

CHU de la Cavale Blanche

Brest, 29609, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

La Timone Adultes

Marseille, 13385, France

Location

Hopital Cochin

Paris, 75014, France

Location

Haut-Lévêque / Radiologie

Pessac, 33604, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

CHU Rouen - Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93207, France

Location

Institut für Radiologie Universitätsklinikum Charité

Berlin, 10117, Germany

Location

University Hospital Erlangen

Erlangen, 191054, Germany

Location

Elisabeth-Krankenhaus Hospital

Essen, 45138, Germany

Location

University Hospital Mannheim

Mannheim, 368167, Germany

Location

University Hospital LMU

Munich, 81377, Germany

Location

Universitätsklinik Ulm

Ulm, 89081, Germany

Location

Ospedale A.Perrino U.O. di radiodiagnostica

Brindisi, Italy

Location

Ospedale del Delta

Ferrara, Italy

Location

Sapienza-universita di Roma

Rome, Italy

Location

Ospedale civile Maggiore du Verona Borgo

Verona, 37126, Italy

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Institut für Radiologie

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

iobitridol; iopromide; iomeprol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof. Dr. med. Martin HOFFMANN
• Organization: Section Head Interventional and Cardiac Radiology - Kantonsspital Lucerne, Spitalstrasse, 6006 Lucerne, Switzerland

martin.hoffmann@luks.ch

+41 41 205 4660

Study Officials

• Martin HOFFMANN, MD

  Kantonsspital Lucerne- Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 16, 2015
• Results First Posted: December 16, 2015

Record last verified: 2015-11

Locations

FR (9); IT (4); ES (3); DE (6); CH (1)