Previous Myocardial InfarctionNCT01888211
Effect of Omega 3 Fatty Acids on Vascular Function
A study testing Omega 3 fatty acid supplementation and Olive Oil in people with Previous Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Previous Myocardial Infarction
- What is being tested?
- Omega 3 fatty acid supplementation and Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myocardial infarction at least 3 months previously.
Who cannot join
- 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
Show all 9Show fewer
- Unable to tolerate the supine position
- Lack of informed consent
- Blood donation within last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Sciences, University of Edinburgh
Edinburgh, Scotland, EH16 4SB
About this study
Official title: 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.
Read the 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.
- Conditions
- Previous Myocardial Infarction
- Being tested
- Omega 3 fatty acid supplementation, Olive Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acid supplementationDietary supplement
2 grams Omacor daily
Olive OilDietary supplement
2 grams olive oil daily
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acid supplementation | Experimental | Omacor 2 grams daily Receives: Dietary Supplement: Omega 3 fatty acid supplementation |
| Olive Oil | Placebo comparator | Olive Oil capsule 2 grams daily Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 6 weeks after omega 3 fatty acids or placebo
Secondary outcomes (2)
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: Measured at 6 weeks after omega 3 fatty acids or placebo
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: Measured at 6 weeks after omega 3 fatty acids or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startDec 2004
- Primary completionJun 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previous Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David E Newby, Study chair, University of EdinburghJehangir N Din, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888211
- Sponsor's protocol ID
- LREC/2003/8/13
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01888211
- Acronym / sponsor ID
- LREC/2003/8/13
- Conditions
- Previous Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acid supplementation | Experimental | Dietary Supplement: Omega 3 fatty acid supplementationOmacor 2 grams daily |
| Olive Oil | Placebo comparator | Dietary Supplement: Olive OilOlive Oil capsule 2 grams daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myocardial infarction at least 3 months previously.
Key exclusion criteria (9 listed)
- Dietary fish allergy or intolerance
- Women of child bearing potential
- Malignant arrhythmias
- Renal or hepatic failure
- Severe or significant co-morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acid supplementation2 grams Omacor daily | Dietary supplement | Omega 3 fatty acid supplementation |
| Olive Oil2 grams olive oil daily | Dietary supplement | Olive Oil |
Primary outcome
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.
2 secondary outcomes
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
Circulating platelet-monocyte aggregates (%).
Time frame: Measured at 6 weeks after omega 3 fatty acids or placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby study chair
University of Edinburgh
Jehangir N Din principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 fatty acid supplementation and Olive Oil in people with Previous Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1) (time frame: Measured at 6 weeks after omega 3 fatty acids or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.