NCT00209404

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

August 18, 2005

Last Update Submit

October 30, 2007

Conditions

Coronary Artery Disease

Keywords

MDCTCoronary ArteryHeart RateImage QualityDiagnostic Quality

Outcome Measures

Primary Outcomes (1)

  • Change in mean heart rate

Secondary Outcomes (4)

  • Image quality

  • Diagnostic quality

  • Overall diagnostic information

  • Frequency and intensity of adverse events

Interventions

Iodixanol 320 mg I/MlDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amersham Health S.A.

Vélizy-Villacoublay, 78457, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

iodixanol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jean-Paul Antonini

    GE Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2005

First Posted

September 21, 2005

Study Start

July 1, 2005

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

FR(1)