The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Omacor (omega-3-acid ethyl esters)


Participation Criteria
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Eligibility Criteria
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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 Pregnancy Oral contraceptive use Ejection fraction <40% Underlying atrial or ventricular arrhythmia History of rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, placebo-controlled, randomized, double-blind trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fish oil<br> | Drug: Omacor (omega-3-acid ethyl esters)<br> <br> |
| Placebo Comparator: placebo<br> | Drug: Omacor (omega-3-acid ethyl esters)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months | Percent change in flow-mediated vasodilation by brachial artery ultrasound | 2 months | 
| Change in heart rate variability indices at 2 months | Change in heart rate variability indices on holter monitor | 2 months | 
| Percent change in carotid intimal media thickness at 12 months | Percent change in carotid intimal media thickness on ultrasound | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QT dispersion interval at 2 months | Change in QT dispersion interval on holter monitor | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness, QT dispersion