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

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ClinicalTrials.gov Identifier: NCT01841944
Recruitment Status : Unknown
Verified October 2014 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : April 29, 2013
Last Update Posted : April 27, 2015
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by (Responsible Party):
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 and revascularizations 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)
Estimated Enrollment : 1400 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
Study Start Date : November 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2019

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 and revascularization. [ 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


Contacts
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Contact: Svein Solheim, MD Phd 23027541 ext +47 svein.solheim@ous-hf.no

Locations
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Norway
Asker and Bærum Hospital Recruiting
Rud, Bærum, Norway, 1309
Contact: Arnljot Tveit, MD Phd       arnljot.tveit@vestreviken.no   
Akershus university hospital HF Recruiting
Lørenskog, Norway, 1478
Contact: Pål Smith, MD Phd         
Principal Investigator: Peder Myhre, MD         
Oslo University Hospital(Ullevaal) Recruiting
Oslo, Norway, 0424
Principal Investigator: Kristian Laake, MD         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Asker & Baerum Hospital
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01841944     History of Changes
Other Study ID Numbers: 2012/14890
2012-004478-25 ( EudraCT Number )
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: October 2014
Keywords provided by 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