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Effect of Omega 3 Fatty Acids on Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888211
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Previous Myocardial Infarction Dietary Supplement: Omega 3 fatty acid supplementation Dietary Supplement: Olive Oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction
Study Start Date : December 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888211


Locations
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United Kingdom
Centre for Cardiovascular Sciences, University of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
Investigators
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Study Chair: David E Newby University of Edinburgh
Principal Investigator: Jehangir N Din University of Edinburgh
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01888211    
Other Study ID Numbers: LREC/2003/8/13
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases