Myocardial InfarctionOMEMINCT01841944
Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
A study testing Pikasol and Corn oil in people with Myocardial Infarction and Heart Failure, run by Oslo University Hospital at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 82 years
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Myocardial Revascularization
- What is being tested?
- Pikasol and Corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,027 participants
- Where
- 4 sitesNorway
- Study dates
- Nov 2012to 26 Jun 2020
- 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 70 to 82 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with acute myocardial infarction discharged from hospital alive
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Akershus university hospital HF
Lørenskog, 1478
Oslo University Hospital(Ullevaal)
Oslo, 0424
Asker and Bærum Hospital
Rud, Bærum, 1309
Stavanger University Hospital
Stavanger
About this study
Official title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
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%.
- Being tested
- Pikasol, Corn oil
- Keywords
- Fatty Acids, Omega-3, Aged, Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PikasolDrug
Also called omega-3, polyunsaturated fatty acids
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
Corn oilOther
Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer
| Study group | Role | What they receive |
|---|---|---|
| Pikasol | Active comparator | Pikasol®, 3 capsules (1.8 g EPA+DHA)/day Receives: Drug: Pikasol |
| Corn oil | Placebo comparator | 3x capsules of corn oil pr day Receives: Other: Corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
Measured: 24months
Secondary outcomes (1)
Occurence of new onset atrial fibrillation
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startNov 2012
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Asker & Baerum Hospital, Helse Stavanger HF
- Responsible party
- Principal investigator, Are Annesønn Kalstad, Oslo University Hospital
- Investigators
- Harald Arnesen, MD Phd, Study chair, Center for Clinical Heart ResearchSvein Solheim, MD phd, Study director, Center for Clinical Heart ResearchIngebjørg Seljeflot, Phd, Study director, Center for Clinical Heart ResearchKristian Laake, MD, Principal investigator, Center for Clinical Heart ResearchPeder Myhre, MD, Principal investigator, Center for Clinical Heart ResearchAre A Kalstad, MD, Principal investigator, Center for Clinical Heart Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841944
- Sponsor's protocol ID
- 2012/14890
- Other IDs
- 2012-004478-25
- Acronym
- OMEMI
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2013
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34742136Kalstad 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.
PubMed 33650449Kalstad 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.
PubMed 33191772Kalstad 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.
PubMed 31881852Laake 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.
PubMed 24928284
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT01841944
- Acronym / sponsor ID
- OMEMI / 2012/14890
- Keywords
- Fatty Acids, Omega-3, Aged, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Asker & Baerum Hospital, Helse Stavanger HF
- Study start
- Nov 2012 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 29 Apr 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 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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pikasol | Active comparator | Drug: PikasolPikasol®, 3 capsules (1.8 g EPA+DHA)/day |
| Corn oil | Placebo comparator | Other: Corn oil3x capsules of corn oil pr day |
Who may qualify
- Ages
- 70 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with acute myocardial infarction discharged from hospital alive
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| PikasolAlso: omega-3, polyunsaturated fatty acidsPikasol®, 3 capsules (1.8 g EPA+DHA)/day | Drug | Pikasol |
| Corn oilCorn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer | Other | Corn oil |
Primary outcome
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
Time frame: 24months
1 secondary outcome
Occurence of new onset atrial fibrillation
Time frame: 24months
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 19 Aug 2020.
- Derived from this study: PubMed 34742136Chiva-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.
- Derived from this study: PubMed 33650449Kalstad 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.
- Derived from this study: PubMed 33191772Kalstad 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.
- Derived from this study: PubMed 31881852Kalstad 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.
- Derived from this study: PubMed 24928284Laake 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.
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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.
Harald Arnesen, MD Phd study chair
Center for Clinical Heart Research
Svein Solheim, MD phd study director
Center for Clinical Heart Research
Ingebjørg Seljeflot, Phd study director
Center for Clinical Heart Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pikasol and Corn oil in people with Myocardial Infarction and Heart Failure, run by Oslo University Hospital at 4 sites in Norway.
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 4 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841944, which also lists 5 linked publications.
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 19 Aug 2020.