Effect of Omega 3 Fatty Acids on Vascular Function

June 24, 2013 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SB
        • Centre for Cardiovascular Sciences, University of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega 3 fatty acid supplementation
Omacor 2 grams daily
Dietary supplement: Omega 3 fatty acid supplementation
2 grams Omacor daily
Placebo Comparator: Olive Oil
Olive Oil capsule 2 grams daily
Dietary supplement: Olive Oil
2 grams olive oil daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Measured at 6 weeks after omega 3 fatty acids or placebo
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.
Measured at 6 weeks after omega 3 fatty acids or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Study Chair: David E Newby, University of Edinburgh
  • Principal Investigator: Jehangir N Din, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LREC/2003/8/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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