Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Omega 3 fatty acid supplementation
Omacor 2 grams daily
Intervention: Omega 3 fatty acid supplementation (Dietary Supplement)
Olive Oil
Olive Oil capsule 2 grams daily
Intervention: Olive Oil (Dietary Supplement)
Outcomes
Primary Outcomes
Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)
Time Frame: Measured at 6 weeks after omega 3 fatty acids or placebo
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.
Secondary Outcomes
- Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1)(Measured at 6 weeks after omega 3 fatty acids or placebo)
- Circulating platelet-monocyte aggregates (%).(Measured at 6 weeks after omega 3 fatty acids or placebo)