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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Oslo University Hospital
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01841944
First received: April 16, 2013
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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 Intervention
Myocardial Infarction
Heart Failure
Myocardial Revascularization
Atrial Fibrillation
Drug: Pikasol
Other: Corn oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Combined total mortality, first event of non-fatal myocardial infarction, stroke and revascularization. [ Time Frame: 24months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of new onset atrial fibrillation [ Time Frame: 24months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Corn oil

  Eligibility

Ages Eligible for Study:   70 Years to 82 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841944

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

Locations
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
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

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01841944     History of Changes
Other Study ID Numbers: 2012/14890, 2012-004478-25
Study First Received: April 16, 2013
Last Updated: April 24, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Fatty Acids, Omega-3
Aged
Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Atrial Fibrillation
Heart Failure
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014