Phase 3
Completed N=358
Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging
Myocardial Infarction · Death, Sudden, Cardiac
Source: ClinicalTrials.gov NCT00729430 ↗
Enrolled (actual)
358
Serious AEs
0.3%
Results posted
Jun 2017
Primary outcomePrimary: Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling — -5.4; 1.2 Percent Change
◆ Published Evidence
Highly cited
170citations · ~17 / year
Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial.
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.
Linked Publications (3)
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Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial.
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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.
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling |
-5.4; 1.2 | — |
| SECONDARY Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis |
-2.1; 3.4 | — |
| SECONDARY Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction |
4.8; 2.1 | — |
| SECONDARY Effect of Omega-3 Fatty Acids on Infarct Size |
-8.8; -1.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00729430) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.