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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00729430
First received: August 4, 2008
Last updated: May 25, 2017
Last verified: May 2017
August 4, 2008
May 25, 2017
August 2008
October 2013   (Final data collection date for primary outcome measure)
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling [ Time Frame: Before and after study treatments ]
Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)
Predictive value of peri-infarct zone on sudden cardiac death [ Time Frame: 5 Years ]
Complete list of historical versions of study NCT00729430 on ClinicalTrials.gov Archive Site
  • Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]
    Measured 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 Fraction [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]
    Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)
  • Effect of Omega-3 Fatty Acids on Infarct Size [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ]
    Measured as change in infarct size from baseline to post-treatment (6-months)
Effect of Omega-3 fatty acids on Sudden Cardiac Death post STEMI [ Time Frame: 5 years ]
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Myocardial Infarction
  • Death, Sudden, Cardiac
  • Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
    4 grams of omega-3 fatty acids taken orally once per day for 6 months
    Other Name: Lovaza (GlaxoSmithKline)
  • Drug: Placebo
    Placebo tablets taken orally once per day for 6 months
    Other Name: Corn oil placebo
  • Experimental: Omega-3 Fatty Acids
    Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
    Intervention: Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
  • Placebo Comparator: Placebo
    Participants will receive placebo for 6 months.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
358
July 2014
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00729430
591
R01HL091157-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Plan to share data with GISSI Heart Failure group for pooling and meta-analysis
Raymond Y. Kwong, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • GlaxoSmithKline
Principal Investigator: Raymond Y. Kwong, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP