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

NCT00729430 | Completed Phase 3 Results DMC

• 2 other identifiers: 591R01HL091157-01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Death, Sudden, Cardiac

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Before and after study treatments

Secondary Outcomes (3)

• 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

• 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

• Effect of Omega-3 Fatty Acids on Infarct Size

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

Study Arms (2)

Omega-3 Fatty Acids

EXPERIMENTAL

Participants will receive a highly purified form of omega-3 fatty acids for 6 months.

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

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for 6 months.

Drug: Placebo

Interventions

Omega-3 Fatty Acids (Fish Oil Supplements) DRUG

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

Also known as: Lovaza (GlaxoSmithKline)

Omega-3 Fatty Acids

Placebo DRUG

Placebo tablets taken orally once per day for 6 months

Also known as: Corn oil placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Brigham and Women's Hospital, Shapiro Cardiovascular Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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. doi: 10.1161/CIRCULATIONAHA.106.613414. Epub 2006 Jun 26.

  PMID: 16801462 BACKGROUND

• 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.

  PMID: 27482002 RESULT

• 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.

  PMID: 31948661 DERIVED

• 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.

  PMID: 31532795 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Death, Sudden, Cardiac; Heart Arrest

Interventions

Fatty Acids, Omega-3; Omacor; halofantrine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Limitations and Caveats

The study was not powered to evaluate for clinical heart failure and hard cardiac outcomes. A prospective trial would be necessary to determine the effect of earlier and high-dose omega-3 fatty acid therapy on improving clinical outcomes.

Results Point of Contact

• Title: Dr. Raymond Y. Kwong, Director of Cardiac Magnetic Resonance Imaging
• Organization: Brigham and Women's Hospital

rykwong@partners.org

857-307-1960

Study Officials

• Raymond Y. Kwong, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: July 1, 2014
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)