OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction

Stiftung Institut fuer Herzinfarktforschung3,800 enrolled

Overview

Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

3,800

Conditions

Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI) * Ability to take Ω-3-FAE or olive oil without risk * Informed consent Exclusion Criteria: * Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation) * Known hypersensitivity to study medication * Dislike of fish oil * Haemorrhagic diathesis * Unwillingness to discontinue other medications containing fish oil * Legal incapacity * History of drug or alcohol abuse within 6 months * Any investigational therapy within one month of signing informed consent form

Locations (10)

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Johanniter-Krankenhaus Rheinhausen

Duisburg, Germany

Elisabeth-Krankenhaus

Essen, Germany

Staedt. Kliniken Frankfurt/Main-Hoechst

Frankfurt am Main, Germany

Klinikum Fuerth

Fürth, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Klinikum Ingolstadt

Ingolstadt, Germany

Klinikum Neustadt

Neustadt/Aisch, Germany

Elisabeth-Krankenhaus

Recklinghausen, Germany

Marienkrankenhaus

Soest, Germany

Outcomes

Primary Outcomes

Sudden cardiac death

Time frame: 12 months

Secondary Outcomes

Total mortality

Time frame: 12 months

MACCE: Total mortality, re-infarction or stroke

Time frame: 12 months

Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days

Time frame: 12 months

Total rehospitalisation

Time frame: 12 months

Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)

Time frame: 12 months

Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).

Time frame: 12 months

Effect on the severity of depressive co-morbidity in patients surviving an acute myocardial infarction for one year: Mean BDI-II-Depression score and percentage of patients with BDI-II score ≥ 14

Time frame: after 12 months

Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months

Time frame: 12 months

Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months

Time frame: 12 months