Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging (OmegaREMODEL)
|Myocardial Infarction Death, Sudden, Cardiac||Drug: Omega-3 Fatty Acids (Fish Oil Supplements) Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction|
- Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling [ Time Frame: Before and after study treatments ]Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)
- Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)
- Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)
- Effect of Omega-3 Fatty Acids on Infarct Size [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]Measured as change in infarct size from baseline to post-treatment (6-months)
|Study Start Date:||August 2008|
|Study Completion Date:||July 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Omega-3 Fatty Acids
Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
4 grams of omega-3 fatty acids taken orally once per day for 6 months
Other Name: Lovaza (GlaxoSmithKline)
Placebo Comparator: Placebo
Participants will receive placebo for 6 months.
Placebo tablets taken orally once per day for 6 months
Other Name: Corn oil placebo
A new MRI technique to examine the heart was recently developed. In this study, researchers will use this new technique to evaluate the heart in people who have recently had a heart attack to determine whether a specific pattern of heart muscle damage is related to sudden cardiac death. This fatal condition, also known as cardiac arrest, occurs when the heart abruptly stops pumping blood to the body, resulting in loss of consciousness, absence of pulse, and a stop in breathing. The most common cause of sudden cardiac death is a heart attack.
In addition to evaluating the new heart MRI technique, this study will also examine the effects of fish oil supplementation in people who have recently had a heart attack. Recent research has shown that omega-3 fatty acids, commonly found in fish oil, may be beneficial for people with heart conditions. Lastly, the study will determine whether specific biomarkers and genetic factors can help predict the likelihood of a person dying from sudden cardiac death after previously experiencing a heart attack.
Apart from studying the likelihood of sudden cardiac death, This study will measure the change in structure and pumping function of the heart (known as ventricular remodeling) and this study will determine if the high dose of fish oil treatment will result in an improvement of the heart.
This study will enroll people who have had a heart attack in the 2 to 4 weeks before study entry. At a baseline study visit, participants will undergo an MRI of their heart and complete an exercise stress test on a treadmill. A blood sample will be collected, and women will provide a urine sample for a pregnancy test. Questionnaires asking about diet, medical history, and emotions will also be completed. Participants will then be randomly assigned to receive either fish oil supplements or placebo on a daily basis for 6 months. Every 2 to 3 months, study researchers will call participants to check on their health and progress. At a study visit at Month 6, participants will undergo repeat baseline testing. After this visit, study researchers will call participants every 6 months for 3 years to follow up on participants' health status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729430
|United States, Massachusetts|
|Brigham and Women's Hospital, Shapiro Cardiovascular Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Raymond Y. Kwong, MD, MPH||Brigham and Women's Hospital|