Phase 3 N=358 Randomized Triple-blind Treatment

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

Myocardial Infarction · Death, Sudden, Cardiac

Bottom Line

View on ClinicalTrials.gov: NCT00729430 ↗

Enrolled (actual)

358

Serious AEs

0.3%

Results posted

Jun 2017

Primary outcome: Primary: Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling — -5.4; 1.2 Percent Change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Omega-3 Fatty Acids (Fish Oil Supplements) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Oct 2013

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00729430). 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.