Myocardial infarction Circulatory System Acute myocardial infarction
Conditions
Interventions
Based on the inclusion criteria, a first 24-hour Holter recording will be performed. Two to five days later, screened patients still eligible for the study will undergo a second 24-hour Holter recordi
Sponsors
Solvay Pharmaceuticals GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 40 years or older 2. Recent sustained acute myocardial infarction (AMI) 3. Women of childbearing age are subject to pregnancy testing and must agree to maintain adequate hormonal contraception 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Clinically or hemodynamically unstable condition 2. Further invasive investigation, a percutaneous transluminal coronary angioplasty (PTCA) or a coronary atrery bypass graft (CABG) are required 3. Sustained antiarrhythmic therapy (other than a beta-blocking agent administered in the context of secondary prevention of MI) 4. Severe concomitant illness (related to any body organ or system) that is likely to affect outcome assessment 5. Compliance problems 6. Participating in another trial within the past 30 days 7. Pregnant or lactating 8. Known hypersensitivity to the ingredients in Omacor or intolerability to olive oil 9. Diabetes mellitus type I and II
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority of Omacor to improve HRV from baseline to endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in time domain HRV indices 2. Safety | — |
Countries
Lithuania, Poland
Outcome results
None listed