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Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction (OMEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841944
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Are Annesønn Kalstad, Oslo University Hospital

Study Description
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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%.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Heart Failure Myocardial Revascularization Atrial Fibrillation Drug: Pikasol Other: Corn oil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1027 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Actual Study Start Date : November 2012
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : June 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pikasol
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
 Drug: Pikasol
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
Other Names:
  • omega-3
  • polyunsaturated fatty acids
Placebo Comparator: Corn oil
3x capsules of corn oil pr day
 Other: Corn oil
Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer


Outcome Measures
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Primary Outcome Measures :
  1. Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. [ Time Frame: 24months ]

Secondary Outcome Measures :
  1. Occurence of new onset atrial fibrillation [ Time Frame: 24months ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years to 82 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841944


Locations
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Norway
Asker and Bærum Hospital
Rud, Bærum, Norway, 1309
Akershus university hospital HF
Lørenskog, Norway, 1478
Oslo University Hospital(Ullevaal)
Oslo, Norway, 0424
Stavanger University Hospital
Stavanger, Norway
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Asker & Baerum Hospital
Helse Stavanger HF
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Are Annesønn Kalstad, Medical Doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01841944    
Other Study ID Numbers: 2012/14890
2012-004478-25 ( EudraCT Number )
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Keywords provided by Are Annesønn Kalstad, Oslo University Hospital:
Fatty Acids, Omega-3
Aged
Myocardial Infarction
Additional relevant MeSH terms:
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Atrial Fibrillation
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases