The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Age >18 and <75.
Exclusion Criteria
- •Baseline fish oil intake ≥1g/day or fish intake >100g/day
- •Need for urgent or emergent CABG
- •Contraindication for plavix, aspirin or statin
- •Gastrointestinal malabsorption syndrome
- •Oral contraceptive use
- •Ejection fraction <40%
- •Underlying atrial or ventricular arrhythmia
- •History of rheumatoid arthritis
Arms & Interventions
fish oil
Intervention: Omacor (omega-3-acid ethyl esters) (Drug)
placebo
Intervention: Omacor (omega-3-acid ethyl esters) (Drug)
Outcomes
Primary Outcomes
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Time Frame: 2 months
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Percent change in carotid intimal media thickness at 12 months
Time Frame: 2 months
Percent change in carotid intimal media thickness on ultrasound
Change in heart rate variability indices at 2 months
Time Frame: 2 months
Change in heart rate variability indices on holter monitor
Secondary Outcomes
- Change in QT dispersion interval at 2 months(2 months)
Investigators
Sheba Meymandi
Director, Cardiovascular Research
University of California, Los Angeles