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Completed

NCT Number: NCT01888211

Effect of Omega 3 Fatty Acids on Vascular Function

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.

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Key information

Conditions

Previous Myocardial Infarction

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Cardiovascular Sciences, University of Edinburgh

Edinburgh, Scotland, EH16 4SB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3 fatty acid supplementation

Dietary Supplement

2 grams Omacor daily

Olive Oil

Dietary Supplement

2 grams olive oil daily

Primary outcomes

  1. 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

  1. Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1)

    Time frame: Measured at 6 weeks after omega 3 fatty acids or placebo

    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.

  2. Circulating platelet-monocyte aggregates (%).

    Time frame: Measured at 6 weeks after omega 3 fatty acids or placebo

    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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Jun 27, 2013
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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