The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
NCT ID: NCT00454493
Last Updated: 2019-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2006-08-31
2008-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fish oil
Omacor (omega-3-acid ethyl esters)
placebo
Omacor (omega-3-acid ethyl esters)
Interventions
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Omacor (omega-3-acid ethyl esters)
Eligibility Criteria
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Inclusion Criteria
2. Age \>18 and \<75.
Exclusion Criteria
2. Need for urgent or emergent CABG
3. Contraindication for plavix, aspirin or statin
4. Gastrointestinal malabsorption syndrome
5. Pregnancy
6. Oral contraceptive use
7. Ejection fraction \<40%
8. Underlying atrial or ventricular arrhythmia
9. History of rheumatoid arthritis
18 Years
75 Years
ALL
No
Sponsors
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Reliant Pharmaceuticals
INDUSTRY
Olive View-UCLA Education & Research Institute
OTHER
Responsible Party
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Sheba Meymandi
Director, Cardiovascular Research
Principal Investigators
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Sheba K Meymandi, M.D., FACC
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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OV-UCLA Medical Center
Sylmar, California, United States
Countries
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Other Identifiers
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05H-561610
Identifier Type: -
Identifier Source: org_study_id
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