Clinical trial NCT01841944: Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
Official title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Heart Failure
Myocardial Revascularization
Atrial Fibrillation
Keywords: Fatty Acids, Omega-3
Aged
Myocardial Infarction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Asker & Baerum Hospital
name: Helse Stavanger HF
First posted: 2013-04-29
Enrollment: 1027
Sex: ALL
Minimum age (years): 70
Maximum age (years): 82
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.


Eligibility criteria: Inclusion Criteria:

* Patients with acute myocardial infarction discharged from hospital alive

Exclusion Criteria:

* 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

Primary outcomes:
measure: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
timeFrame: 24months
Secondary outcomes:
measure: Occurence of new onset atrial fibrillation
timeFrame: 24months
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Asker and Bærum Hospital
state: Bærum
city: Lørenskog
country: Norway
facility: Akershus university hospital HF
city: Oslo
country: Norway
facility: Oslo University Hospital(Ullevaal)
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Center for Clinical Heart Research
name: Harald Arnesen, MD Phd
role: STUDY_CHAIR
affiliation: Center for Clinical Heart Research
name: Svein Solheim, MD phd
role: STUDY_DIRECTOR
affiliation: Center for Clinical Heart Research
name: Ingebjørg Seljeflot, Phd
role: STUDY_DIRECTOR
affiliation: Center for Clinical Heart Research
name: Kristian Laake, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Clinical Heart Research
name: Peder Myhre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Clinical Heart Research
name: Are A Kalstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kalstad 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.
citation: Kalstad 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.
citation: Kalstad 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.
citation: Laake 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.