NCT01841944: OMEMI

Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality

Completed NA Last updated 18 August 2020

What this trial tests

NA trial testing Pikasol in Myocardial Infarction in 1,027 participants. Completed in 26 June 2020.

Timeline

1 November 2012

Primary endpoint
26 June 2020

26 June 2020

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,027
Start date	1 November 2012
Primary completion	26 June 2020
Estimated completion	26 June 2020
Sites	4 locations across Norway

Drugs / interventions tested

• Pikasol — full drug profile →
• Corn oil — full drug profile →

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Heart Failure — all drugs for Heart Failure →
• Myocardial Revascularization — all drugs for Myocardial Revascularization →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Oslo University Hospital

Who can join

Adults 70 to 82, any sex, with Myocardial Infarction or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
  Time frame: 24months

Sponsor's own description

The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The landscape of aging.
   Cai Y, Song W, Li J, Jing Y, et al · · 2022 · cited 312× · PMID 36066811 · DOI 10.1007/s11427-022-2161-3
2. Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction: A Randomized, Controlled Trial.
   Kalstad AA, Myhre PL, Laake K, Tveit SH, et al · · 2021 · cited 228× · PMID 33191772 · DOI 10.1161/circulationaha.120.052209
3. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.
   Abdelhamid AS, Brown TJ, Brainard JS, Biswas P, et al · · 2020 · cited 203× · PMID 32114706 · DOI 10.1002/14651858.cd003177.pub5
4. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.
   Abdelhamid AS, Brown TJ, Brainard JS, Biswas P, et al · · 2018 · cited 150× · PMID 30019766 · DOI 10.1002/14651858.cd003177.pub3
5. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.
   Abdelhamid AS, Brown TJ, Brainard JS, Biswas P, et al · · 2018 · cited 125× · PMID 30521670 · DOI 10.1002/14651858.cd003177.pub4
6. Platelet-, monocyte-derived and tissue factor-carrying circulating microparticles are related to acute myocardial infarction severity.
   Chiva-Blanch G, Laake K, Myhre P, Bratseth V, et al · · 2017 · cited 80× · PMID 28207887 · DOI 10.1371/journal.pone.0172558
7. Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease.
   Abdelhamid AS, Martin N, Bridges C, Brainard JS, et al · · 2018 · cited 56× · PMID 30484282 · DOI 10.1002/14651858.cd012345.pub3
8. Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease.
   Abdelhamid AS, Martin N, Bridges C, Brainard JS, et al · · 2018 · cited 53× · PMID 30019767 · DOI 10.1002/14651858.cd012345.pub2