Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging (OmegaREMODEL)

Tracking Information
First Submitted Date ICMJE	August 4, 2008
First Posted Date ICMJE	August 7, 2008
Results First Submitted Date	February 28, 2017
Results First Posted Date	June 1, 2017
Last Update Posted Date	June 1, 2017
Study Start Date ICMJE	August 2008
Actual Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 25, 2017)	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)
Original Primary Outcome Measures ICMJE; (submitted: August 6, 2008)	Predictive value of peri-infarct zone on sudden cardiac death [ Time Frame: 5 Years ]
Change History	Complete list of historical versions of study NCT00729430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 25, 2017)	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)
Original Secondary Outcome Measures ICMJE; (submitted: August 6, 2008)	Effect of Omega-3 fatty acids on Sudden Cardiac Death post STEMI [ Time Frame: 5 years ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging
Official Title ICMJE	Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction
Brief Summary	Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Myocardial Infarction; Death, Sudden, Cardiac
Intervention ICMJE	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); Drug: Placebo Placebo tablets taken orally once per day for 6 months Other Name: Corn oil placebo
Study Arms	Experimental: Omega-3 Fatty Acids Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Intervention: Drug: Omega-3 Fatty Acids (Fish Oil Supplements); Placebo Comparator: Placebo Participants will receive placebo for 6 months. Intervention: Drug: Placebo
Publications *	Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. Epub 2006 Jun 26.; Heydari B, Abdullah S, Pottala JV, Shah R, Abbasi S, Mandry D, Francis SA, Lumish H, Ghoshhajra BB, Hoffmann U, Appelbaum E, Feng JH, Blankstein R, Steigner M, McConnell JP, Harris W, Antman EM, Jerosch-Herold M, Kwong RY. Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial. Circulation. 2016 Aug 2;134(5):378-91. doi: 10.1161/CIRCULATIONAHA.115.019949.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 25, 2017)	358
Original Estimated Enrollment ICMJE; (submitted: August 6, 2008)	414
Actual Study Completion Date	July 2014
Actual Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Experienced a heart attack in the 2 to 4 weeks before study entry; Lives in the greater Boston area or adjacent regions (within a 50-mile radius of Boston) Exclusion Criteria: Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an implantable cardioverter defibrillator [AICD]) at time of study entry; Active cancer or any other terminal illness with an expected survival rate of less than 6 months after study entry; Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60 mL/min in the 2 weeks before study entry; Inability to follow study procedures; Pregnant; Hemodynamic instability; Urgent clinical need for a pacemaker or AICD; Inaccessibility of medical records
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00729430
Other Study ID Numbers ICMJE	591; R01HL091157-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: Plan to share data with GISSI Heart Failure group for pooling and meta-analysis
Responsible Party	Raymond Y. Kwong, MD, Brigham and Women's Hospital
Study Sponsor ICMJE	Brigham and Women's Hospital
Collaborators ICMJE	National Heart, Lung, and Blood Institute (NHLBI); GlaxoSmithKline
Investigators ICMJE	Principal Investigator: Raymond Y. Kwong, MD, MPH Brigham and Women's Hospital
PRS Account	Brigham and Women's Hospital
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP