Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction at least 3 months previously.
排除标准
- •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
研究组 & 干预措施
Omega 3 fatty acid supplementation
Omacor 2 grams daily
干预措施: Omega 3 fatty acid supplementation (Dietary Supplement)
Olive Oil
Olive Oil capsule 2 grams daily
干预措施: Olive Oil (Dietary Supplement)
结局指标
主要结局
Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)
时间窗: 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.
次要结局
- 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)