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Sponsors and Collaborators: |
University of California, Los Angeles Reliant Pharmaceuticals |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00454493 |
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.
Condition | Intervention |
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Coronary Artery Disease |
Drug: Omacor (omega-3-acid ethyl esters) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease |
Estimated Enrollment: | 100 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | July 2008 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sheba K Meymandi, M.D.,FACC | 818-364-4287 | smeymandi@ladhs.org |
Contact: Mahmoud I Traina, M.D. | 818-364-4287 | mitraina@gmail.com |
United States, California | |
OV-UCLA Medical Center | Recruiting |
Sylmar, California, United States, 91342 |
Principal Investigator: | Sheba K Meymandi, M.D., FACC | University of California, Los Angeles |
Study ID Numbers: | 05H-561610 |
Study First Received: | March 29, 2007 |
Last Updated: | March 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00454493 History of Changes |
Health Authority: | United States: Institutional Review Board |
omacor fish oil omega 3 fatty acids coronary artery disease |
endothelial function heart rate variability carotid intimal media thickness QT dispersion |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Omega 3 Fatty Acid |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |