An interventional study of Omacor (omega-3-acid ethyl esters) in Coronary Artery Disease, sponsored by Olive View-UCLA Education & Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Olive View-UCLA Education & Research Institute · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy.
One hundred patients with established coronary artery disease by coronary angiography will undergo randomization for enrollment in the study. Baseline evaluation will include assessment of brachial artery endothelial function, heart rate variability and carotid intimal media thickness. Evaluation of the endothelial function of the brachial artery will be elucidated by inflation of a blood pressure cuff around the arm for five minutes and measuring blood vessel dynamics after release of the cuff. Heart rate variability will be evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal media thickness will be evaluated by ultrasound measurements guided by predetermined protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at 2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 71 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Olive View-UCLA Education & Research Institute is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Drug: Omacor (omega-3-acid ethyl esters)
Drug: Omacor (omega-3-acid ethyl esters)
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Time frame: 2 months
Change in heart rate variability indices at 2 months
Change in heart rate variability indices on holter monitor
Time frame: 2 months
Percent change in carotid intimal media thickness at 12 months
Percent change in carotid intimal media thickness on ultrasound
Time frame: 2 months
Change in QT dispersion interval at 2 months
Change in QT dispersion interval on holter monitor
Time frame: 2 months
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Olive View-UCLA Education & Research Institute