Effect of Omega 3 Fatty Acids on Vascular Function

Previous Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888211
• Other study ID #: LREC/2003/8/13
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: June 2009

Study information

• Verified date: June 2013
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Previous Myocardial Infarction

Intervention

Dietary Supplement:
• Omega 3 fatty acid supplementation
2 grams Omacor daily
• Olive Oil
2 grams olive oil daily

Locations

Country	Name	City	State
United Kingdom	Centre for Cardiovascular Sciences, University of Edinburgh	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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