Skip to content

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

Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00729430
Acronym
OmegaREMODEL
Enrollment
358
Registered
2008-08-07
Start date
2008-08-31
Completion date
2014-07-31
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Sudden, Cardiac, Myocardial Infarction

Keywords

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

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.

Interventions

DRUGOmega-3 Fatty Acids (Fish Oil Supplements)

4 grams of omega-3 fatty acids taken orally once per day for 6 months

DRUGPlacebo

Placebo tablets taken orally once per day for 6 months

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
GlaxoSmithKline
CollaboratorINDUSTRY
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular RemodelingBefore and after study treatmentsMeasured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)

Secondary

MeasureTime frameDescription
Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial FibrosisMeasured in the 3-year follow-up period after participant's last study visitMeasured 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 FractionMeasured in the 3-year follow-up period after participant's last study visitMeasured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)
Effect of Omega-3 Fatty Acids on Infarct SizeMeasured in the 3-year follow-up period after participant's last study visitMeasured as change in infarct size from baseline to post-treatment (6-months)

Countries

United States

Participant flow

Participants by arm

ArmCount
High Dose Omega-3 Fatty Acid Arm
Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months
180
Placebo Arm
Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
178
Total358

Baseline characteristics

CharacteristicHigh Dose Omega-3 Fatty Acid ArmPlacebo ArmTotal
Age, Continuous60 years
STANDARD_DEVIATION 10
58 years
STANDARD_DEVIATION 10
59 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
180 Participants178 Participants358 Participants
Sex: Female, Male
Female
32 Participants38 Participants70 Participants
Sex: Female, Male
Male
148 Participants140 Participants288 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
18 / 18011 / 178
serious
Total, serious adverse events
1 / 1800 / 178

Outcome results

Primary

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

Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)

Time frame: Before and after study treatments

ArmMeasureValue (MEAN)Dispersion
High Dose Omega-3 Fatty Acid ArmEffect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling-5.4 Percent ChangeStandard Deviation 16.6
Placebo ArmEffect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling1.2 Percent ChangeStandard Deviation 20.9
Secondary

Effect of Omega-3 Fatty Acids on Infarct Size

Measured as change in infarct size from baseline to post-treatment (6-months)

Time frame: Measured in the 3-year follow-up period after participant's last study visit

ArmMeasureValue (MEAN)Dispersion
High Dose Omega-3 Fatty Acid ArmEffect of Omega-3 Fatty Acids on Infarct Size-8.8 Percent ChangeStandard Deviation 39.9
Placebo ArmEffect of Omega-3 Fatty Acids on Infarct Size-1.9 Percent ChangeStandard Deviation 57.7
Secondary

Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction

Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)

Time frame: Measured in the 3-year follow-up period after participant's last study visit

ArmMeasureValue (MEAN)Dispersion
High Dose Omega-3 Fatty Acid ArmEffect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction4.8 Percent ChangeStandard Deviation 11
Placebo ArmEffect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction2.1 Percent ChangeStandard Deviation 12
Secondary

Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis

Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)

Time frame: Measured in the 3-year follow-up period after participant's last study visit

ArmMeasureValue (MEAN)Dispersion
High Dose Omega-3 Fatty Acid ArmEffect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis-2.1 Percent ChangeStandard Deviation 14
Placebo ArmEffect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis3.4 Percent ChangeStandard Deviation 15

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026