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

August 18, 2020 updated by: Are Annesønn Kalstad, Oslo University Hospital

Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1027

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lørenskog, Norway, 1478
        • Akershus University Hospital HF
      • Oslo, Norway, 0424
        • Oslo University Hospital(Ullevaal)
      • Stavanger, Norway
        • Stavanger University Hospital
    • Bærum
      • Rud, Bærum, Norway, 1309
        • Asker and Bærum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 82 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurence of new onset atrial fibrillation
Time Frame: 24months
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Asker & Baerum Hospital
Helse Stavanger HF
University Hospital, Akershus

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
  • Principal Investigator: Are A Kalstad, MD, Center for Clinical Heart Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2012

Primary Completion (ACTUAL)

June 26, 2020

Study Completion (ACTUAL)

June 26, 2020

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/14890
  • 2012-004478-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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