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

This study has been completed.

First Received: August 18, 2005 Last Updated: October 30, 2007 History of Changes

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00209404

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Iodixanol 320 mg I/Ml	Phase IV

MedlinePlus related topics: CT Scans Coronary Artery Disease

Drug Information available for: Iodixanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

Change in mean heart rate

Secondary Outcome Measures:

Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events

Estimated Enrollment:	50
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209404

Locations

France
Amersham Health S.A.
VELIZY CEDEX, France, 78457

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director:

Jean-Paul Antonini

GE Healthcare

More Information

No publications provided

Study ID Numbers:	DXV407
Study First Received:	August 18, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00209404 History of Changes
Health Authority:	France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Spain: Ministry of Health and Consumption

Keywords provided by GE Healthcare:

MDCT
Coronary Artery
Heart Rate
Image Quality
Diagnostic Quality

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009