Highly purified omega-3 fatty acids for secondary prevention of sudden cardiac death after myocardial infarction-aims and methods of the OMEGA-study.
BACKGROUND
During the last decades a large body of data has been accumulated indicating omega-3 fatty acids to exert beneficial effects on the prognosis of patients with cardiovascular disease. Especially, omega-3 fatty acids are regarded to be effective in reducing the risk of sudden cardiac death after acute myocardial infarction. However, treatment of acute myocardial infarction and secondary prevention considerably have been improved within the past years including early revascularization by PCI, the routine use of beta-blockers, statins and ACE-inhibitors as well as cardiac rehabilitation for improving life style measures. To date, there exists no controlled randomized trial testing the prognostic effect of omega-3 fatty acids after acute myocardial infarction in a double blind regimen under the conditions of modern treatment of myocardial infarction.


METHODS
The present study therefore evaluates the effect of highly purified omega-3 fatty acid ethylesters (omega-3-acid ethyl esters 90=Zodin) on the rate of sudden cardiac death within 1 year after acute myocardial infarction. Secondary endpoints are total mortality, non-fatal cardiovascular events, rhythm abnormalities in holter monitoring and depression score.


CONCLUSIONS
The recruitment-period started in October 2003 and is expected to last until December 2006. The results of the study are therefore expected for the beginning of 2008, when all patients will have completed the 12-months follow up-period.
Rauch
Bernhard
B
Herzzentrum, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
Schiele
Rudolf
R
Schneider
Steffen
S
Gohlke
Helmut
H
Diller
Frank
F
Gottwik
Martin
M
Steinbeck
Gerhard
G
Heer
Tobias
T
Katus
Hugo
H
Zimmer
Reinhilde
R
Erdogan
Ali
A
Pfafferott
Conrad
C
Senges
Jochen
J
D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D003863:Depression / Q000175:diagnosis; D004311:Double-Blind Method; D015716:Electrocardiography, Ambulatory; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006321:Heart / Q000187:drug effects / Q000502:physiology; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology
D015525:Fatty Acids, Omega-3; C511723:zodin