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| Name | Class |
|---|---|
| Reliant Pharmaceuticals | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fish oil | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor (omega-3-acid ethyl esters) | Drug |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT dispersion interval at 2 months | Change in QT dispersion interval on holter monitor | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheba K Meymandi, M.D., FACC | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OV-UCLA Medical Center | Sylmar | California | 91342 | United States |
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prospective, placebo-controlled, randomized, double-blind trial
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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