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

• ClinicalTrials.gov Identifier: NCT00729430
• Recruitment Status: Completed
• First Posted: August 7, 2008
• Results First Posted: June 1, 2017
• Last Update Posted: June 1, 2017
• Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); GlaxoSmithKline
• Information provided by (Responsible Party): Raymond Y. Kwong, MD, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction; Death, Sudden, Cardiac	Drug: Omega-3 Fatty Acids (Fish Oil Supplements); Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 358 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (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
• Study Start Date: August 2008
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Placebo; Placebo tablets taken orally once per day for 6 months; Other Name: Corn oil placebo

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital, Shapiro Cardiovascular Center

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

National Heart, Lung, and Blood Institute (NHLBI)

GlaxoSmithKline

Investigators

• Principal Investigator: Raymond Y. Kwong, MD, MPH; Brigham and Women's Hospital

More Information

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fujikura K, Heydari B, Ge Y, Kaneko K, Abdullah S, Harris WS, Jerosch-Herold M, Kwong RY. Insulin Resistance Modifies the Effects of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction (from the OMEGA-REMODEL Randomized Clinical Trial). Am J Cardiol. 2020 Mar 1;125(5):678-684. doi: 10.1016/j.amjcard.2019.11.032. Epub 2019 Dec 9.

Kwong RY, Heydari B, Ge Y, Abdullah S, Fujikura K, Kaneko K, Harris WS, Jerosch-Herold M, Antman EM, Seidman JG, Pfeffer MA. Genetic profiling of fatty acid desaturase polymorphisms identifies patients who may benefit from high-dose omega-3 fatty acids in cardiac remodeling after acute myocardial infarction-Post-hoc analysis from the OMEGA-REMODEL randomized controlled trial. PLoS One. 2019 Sep 18;14(9):e0222061. doi: 10.1371/journal.pone.0222061. eCollection 2019.

• Responsible Party: Raymond Y. Kwong, MD, Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00729430
• Other Study ID Numbers: 591; R01HL091157-01 ( U.S. NIH Grant/Contract )
• First Posted: August 7, 2008
• Results First Posted: June 1, 2017
• Last Update Posted: June 1, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Plan to share data with GISSI Heart Failure group for pooling and meta-analysis

Keywords provided by Raymond Y. Kwong, MD, Brigham and Women's Hospital:

Heart Attack; Sudden Cardiac Death; Peri-infarct Zone; Omega-3 Fatty Acids; Biological Markers; Cytogenetic Analysis; Cardiac Arrest

Additional relevant MeSH terms:

Myocardial Infarction; Death, Sudden, Cardiac; Infarction; Death, Sudden; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Death; Heart Arrest