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

This study is currently recruiting participants.
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
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

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

ClinicalTrials.gov processed this record on April 15, 2014