Effect of Omega 3 Fatty Acids on Vascular Function

Study Overview
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Brief Summary
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The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and monocyte activation in patients with coronary heart disease.

Detailed Description
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Twenty patients with a previous myocardial infarction were recruited into a randomised, double-blind, placebo-controlled, crossover trial of omega-3 fatty acid supplementation (2g/day for 6-weeks). Peripheral blood was taken for analysis of platelet and monocyte activation, and forearm blood flow was assessed in a subset of 12 patients during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside. Stimulated plasma tissue plasminogen activator (t-PA) concentrations were measured during substance P infusion.

Official Title
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Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction

Conditions
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Previous Myocardial Infarction

Intervention / Treatment
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* Dietary Supplement: Omega 3 fatty acid supplementation
* Dietary Supplement: Olive Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Myocardial infarction at least 3 months previously. Exclusion Criteria: Dietary fish allergy or intolerance Women of child bearing potential Malignant arrhythmias Renal or hepatic failure Severe or significant co-morbidity Previous history of blood dyscrasia Unable to tolerate the supine position Lack of informed consent Blood donation within last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 fatty acid supplementation<br>Omacor 2 grams daily | Dietary Supplement: Omega 3 fatty acid supplementation<br>* 2 grams Omacor daily<br>|
| Placebo Comparator: Olive Oil<br>Olive Oil capsule 2 grams daily | Dietary Supplement: Olive Oil<br>* 2 grams olive oil daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1) | Endogenous fibrinolysis was measured by drawing blood during intrabrachial substance P infusion and then plasma t-PA antigen and activity (t-PA Combi Actibind Elisa Kit; Technoclone, Vienna, Austria) concentrations were determined by enzyme-linked immunosorbent assays. Estimated net release of plasma t-PA was the product of the infused forearm plasma flow (based on the mean hematocrit and the infused forearm blood flow) and the concentration difference between the infused and noninfused arms. | Measured at 6 weeks after omega 3 fatty acids or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1) | Forearm blood flow was measured during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside by venous occlusion plethysmography with mercury-in-silicone elastomer strain gauges. | Measured at 6 weeks after omega 3 fatty acids or placebo | 
| Circulating platelet-monocyte aggregates (%). | Whole blood was immunolabelled with appropriate monoclonal antibodies for subsequent flow cytometric analysis of platelet-monocyte aggregation. Platelet-monocyte aggregates were defined as the percentage of monocytes positive for CD42a. | Measured at 6 weeks after omega 3 fatty acids or placebo |