Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
OMEMI
Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
2 other identifiers
interventional
1,027
1 country
4
Brief Summary
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 16, 2013
CompletedFirst Posted
Study publicly available on registry
April 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedAugust 19, 2020
August 1, 2020
7.7 years
April 16, 2013
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
24months
Secondary Outcomes (1)
Occurence of new onset atrial fibrillation
24months
Study Arms (2)
Pikasol
ACTIVE COMPARATORPikasol®, 3 capsules (1.8 g EPA+DHA)/day
Corn oil
PLACEBO COMPARATOR3x capsules of corn oil pr day
Interventions
Eligibility Criteria
You may qualify if:
- Patients with acute myocardial infarction discharged from hospital alive
You may not qualify if:
- Being part of another randomized trial
- Documented intolerance for omega-3 fatty acids
- Additional disease state that is thought to be incompatible with compliance to the study drugs
- Additional disease state thought to reduce survival for the follow-up time of 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University Hospital, Akershuscollaborator
- Asker & Baerum Hospitalcollaborator
- Helse Stavanger HFcollaborator
Study Sites (4)
Asker and Bærum Hospital
Rud, Bærum, 1309, Norway
Akershus university hospital HF
Lørenskog, 1478, Norway
Oslo University Hospital(Ullevaal)
Oslo, 0424, Norway
Stavanger University Hospital
Stavanger, Norway
Related Publications (5)
Chiva-Blanch G, Bratseth V, Laake K, Arnesen H, Solheim S, Schmidt EB, Badimon L, Seljeflot I. One year of omega 3 polyunsaturated fatty acid supplementation does not reduce circulating prothrombotic microvesicles in elderly subjects after suffering a myocardial infarction. Clin Nutr. 2021 Dec;40(12):5674-5677. doi: 10.1016/j.clnu.2021.10.007. Epub 2021 Oct 20.
PMID: 34742136DERIVEDKalstad AA, Myhre PL, Laake K, Opstad TB, Tveit A, Solheim S, Arnesen H, Seljeflot I. Biomarkers of ageing and cardiac remodeling are associated with atrial fibrillation. Scand Cardiovasc J. 2021 Aug;55(4):213-219. doi: 10.1080/14017431.2021.1889653. Epub 2021 Mar 2.
PMID: 33650449DERIVEDKalstad AA, Myhre PL, Laake K, Tveit SH, Schmidt EB, Smith P, Nilsen DWT, Tveit A, Fagerland MW, Solheim S, Seljeflot I, Arnesen H; OMEMI Investigators. Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction: A Randomized, Controlled Trial. Circulation. 2021 Feb 9;143(6):528-539. doi: 10.1161/CIRCULATIONAHA.120.052209. Epub 2020 Nov 15.
PMID: 33191772DERIVEDKalstad AA, Tveit S, Myhre PL, Laake K, Opstad TB, Tveit A, Schmidt EB, Solheim S, Arnesen H, Seljeflot I. Leukocyte telomere length and serum polyunsaturated fatty acids, dietary habits, cardiovascular risk factors and features of myocardial infarction in elderly patients. BMC Geriatr. 2019 Dec 27;19(1):376. doi: 10.1186/s12877-019-1383-9.
PMID: 31881852DERIVEDLaake K, Myhre P, Nordby LM, Seljeflot I, Abdelnoor M, Smith P, Tveit A, Arnesen H, Solheim S. Effects of omega3 supplementation in elderly patients with acute myocardial infarction: design of a prospective randomized placebo controlled study. BMC Geriatr. 2014 Jun 13;14:74. doi: 10.1186/1471-2318-14-74.
PMID: 24928284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harald Arnesen, MD Phd
Center for Clinical Heart Research
- STUDY DIRECTOR
Svein Solheim, MD phd
Center for Clinical Heart Research
- STUDY DIRECTOR
Ingebjørg Seljeflot, Phd
Center for Clinical Heart Research
- PRINCIPAL INVESTIGATOR
Kristian Laake, MD
Center for Clinical Heart Research
- PRINCIPAL INVESTIGATOR
Peder Myhre, MD
Center for Clinical Heart Research
- PRINCIPAL INVESTIGATOR
Are A Kalstad, MD
Center for Clinical Heart Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
April 16, 2013
First Posted
April 29, 2013
Study Start
November 1, 2012
Primary Completion
June 26, 2020
Study Completion
June 26, 2020
Last Updated
August 19, 2020
Record last verified: 2020-08