Clinical trial NCT00729430: Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging
Official title: Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: GlaxoSmithKline
First posted: 2008-08-07
Enrollment: 358
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling
timeFrame: Before and after study treatments
Secondary outcomes:
measure: Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis
timeFrame: Measured in the 3-year follow-up period after participant's last study visit
measure: Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction
timeFrame: Measured in the 3-year follow-up period after participant's last study visit
measure: Effect of Omega-3 Fatty Acids on Infarct Size
timeFrame: Measured in the 3-year follow-up period after participant's last study visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Shapiro Cardiovascular Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Raymond Y. Kwong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.