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

Phase 3

Completed

Conditions: Death, Sudden, Cardiac
Myocardial Infarction

Interventions: Drug: Placebo
Drug: Omega-3 Fatty Acids (Fish Oil Supplements)

Registration Number: NCT00729430

Lead Sponsor: Brigham and Women's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 358

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo for 6 months.
Omega-3 Fatty Acids	Omega-3 Fatty Acids (Fish Oil Supplements)	Participants will receive a highly purified form of omega-3 fatty acids for 6 months.

Primary Outcome Measures

Name	Time	Method
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling	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

Name	Time	Method
Effect of Omega-3 Fatty Acids on Infarct Size	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)
Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis	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	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)