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

NCT ID: NCT01255722

Last Updated: 2015-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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

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Coronary Artery Disease

Keywords

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iodinated contrast media, coronary artery disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Iobitridol

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

Group Type EXPERIMENTAL

iobitridol

Intervention Type DRUG

single IV injection

Iopromide

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

Group Type ACTIVE_COMPARATOR

iopromide

Intervention Type DRUG

Single IV injection

Iomeprol

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

Group Type ACTIVE_COMPARATOR

iomeprol

Intervention Type DRUG

Single IV injection

Interventions

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iobitridol

single IV injection

Intervention Type DRUG

iopromide

Single IV injection

Intervention Type DRUG

iomeprol

Single IV injection

Intervention Type DRUG

Other Intervention Names

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Xenetix® Ultravist® Iomeron®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin HOFFMANN, MD

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Lucerne- Switzerland

Locations

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CHU Angers

Angers, , France

Site Status

CHU de la Cavale Blanche

Brest, , France

Site Status

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Site Status

La Timone Adultes

Marseille, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Haut-Lévêque / Radiologie

Pessac, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

CHU Rouen - Hopital Charles Nicolle

Rouen, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Institut für Radiologie Universitätsklinikum Charité

Berlin, , Germany

Site Status

University Hospital Erlangen

Erlangen, , Germany

Site Status

Elisabeth-Krankenhaus Hospital

Essen, , Germany

Site Status

University Hospital Mannheim

Mannheim, , Germany

Site Status

University Hospital LMU

Munich, , Germany

Site Status

Universitätsklinik Ulm

Ulm, , Germany

Site Status

Ospedale A.Perrino U.O. di radiodiagnostica

Brindisi, , Italy

Site Status

Ospedale del Delta

Ferrara, , Italy

Site Status

Sapienza-universita di Roma

Rome, , Italy

Site Status

Ospedale civile Maggiore du Verona Borgo

Verona, , Italy

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status

Institut für Radiologie

Sankt Gallen, , Switzerland

Site Status

Countries

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France Germany Italy Spain Switzerland

Other Identifiers

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ISO-44-012

Identifier Type: -

Identifier Source: org_study_id