Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)

NCT ID: NCT00209404

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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MDCT Coronary Artery Heart Rate Image Quality Diagnostic Quality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Iodixanol 320 mg I/Ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate \>75 beats per minute (bpm) will be included.

Exclusion Criteria

* Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jean-Paul Antonini

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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Amersham Health S.A.

Vélizy-Villacoublay, , France

Site Status

Countries

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France

Other Identifiers

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DXV407

Identifier Type: -

Identifier Source: org_study_id