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OpenTrials
Completed

NCT Number: NCT00209404

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amersham Health S.A.

Vélizy-Villacoublay, 78457, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iodixanol 320 mg I/Ml

Drug

Primary outcomes

  1. Change in mean heart rate

Secondary outcomes

  1. Image quality

  2. Diagnostic quality

  3. Overall diagnostic information

  4. Frequency and intensity of adverse events

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2005
First posted
Sep 21, 2005
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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