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| Name | Class |
|---|---|
| Trommsdorff GmbH & Co. KG | INDUSTRY |
| Pronova BioPharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | omega-3-acid ethyl ester 90 |
|
| 2 | Placebo Comparator | olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zodin (drug) | Drug | 1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sudden cardiac death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total mortality | 12 months | |
| MACCE: Total mortality, re-infarction or stroke | 12 months | |
| Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Senges, Prof. Dr. | Stiftung Institut fuer Herzinfarktforschung, Chairman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17124558 | Background | Rauch B, Schiele R, Schneider S, Gohlke H, Diller F, Gottwik M, Steinbeck G, Heer T, Katus H, Zimmer R, Erdogan A, Pfafferott C, Senges J; Omega-Study Group. Highly purified omega-3 fatty acids for secondary prevention of sudden cardiac death after myocardial infarction-aims and methods of the OMEGA-study. Cardiovasc Drugs Ther. 2006 Oct;20(5):365-75. doi: 10.1007/s10557-006-0495-6. | |
| 24330904 |
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| Olive oil (placebo) |
| Drug |
1 gram olive oil daily for a period of 12 months |
|
| 12 months |
| Total rehospitalisation | 12 months |
| Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG) | 12 months |
| Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing). | 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 | after 12 months |
| Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months | 12 months |
| Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months | 12 months |
| Johanniter-Krankenhaus Rheinhausen |
| Duisburg |
| 47228 |
| Germany |
| Elisabeth-Krankenhaus | Essen | 45138 | Germany |
| Staedt. Kliniken Frankfurt/Main-Hoechst | Frankfurt am Main | 65929 | Germany |
| Klinikum Fuerth | Fürth | 90766 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Klinikum Ingolstadt | Ingolstadt | 85049 | Germany |
| Klinikum Neustadt | Neustadt/Aisch | 91413 | Germany |
| Elisabeth-Krankenhaus | Recklinghausen | 45661 | Germany |
| Marienkrankenhaus | Soest | 59494 | Germany |
| Derived |
| Zimmer R, Riemer T, Rauch B, Schneider S, Schiele R, Gohlke H, Diller F, Steinbeck G, Katus H, Senges J; OMEGA-Study Group. Effects of 1-year treatment with highly purified omega-3 fatty acids on depression after myocardial infarction: results from the OMEGA trial. J Clin Psychiatry. 2013 Nov;74(11):e1037-45. doi: 10.4088/JCP.13m08453. |
| 23559535 | Derived | Rauch B, Riemer T, Schwaab B, Schneider S, Diller F, Gohlke H, Schiele R, Katus H, Gitt A, Senges J; OMEGA study group. Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study. Eur J Prev Cardiol. 2014 Sep;21(9):1060-9. doi: 10.1177/2047487313486040. Epub 2013 Apr 4. |
| 21060071 | Derived | Rauch B, Schiele R, Schneider S, Diller F, Victor N, Gohlke H, Gottwik M, Steinbeck G, Del Castillo U, Sack R, Worth H, Katus H, Spitzer W, Sabin G, Senges J; OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation. 2010 Nov 23;122(21):2152-9. doi: 10.1161/CIRCULATIONAHA.110.948562. Epub 2010 Nov 8. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C511723 | zodin |
| D004364 | Pharmaceutical Preparations |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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