Coronary Artery Disease
Conditions
Keywords
omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness, QT dispersion
Brief summary
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.
Interventions
Sponsors
Reliant Pharmaceuticals
Olive View-UCLA Education & Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Intervention model description
prospective, placebo-controlled, randomized, double-blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Established coronary artery disease as determined by coronary angiography within the last 5 years demonstrating at least 50% stenosis in one of the major coronary vessels 2. Age \>18 and \<75.
Exclusion criteria
1. Baseline fish oil intake ≥1g/day or fish intake \>100g/day 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate variability indices at 2 months | 2 months | Change in heart rate variability indices on holter monitor |
| Percent change in carotid intimal media thickness at 12 months | 2 months | Percent change in carotid intimal media thickness on ultrasound |
| Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months | 2 months | Percent change in flow-mediated vasodilation by brachial artery ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QT dispersion interval at 2 months | 2 months | Change in QT dispersion interval on holter monitor |
Countries
United States
Outcome results
None listed