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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
  Purpose
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.

Condition Intervention Phase
Myocardial Infarction Death, Sudden, Cardiac Drug: Omega-3 Fatty Acids (Fish Oil Supplements) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Raymond Y. Kwong, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 358
Study Start Date: August 2008
Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 Fatty Acids
Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
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)
Placebo Comparator: Placebo
Participants will receive placebo for 6 months.
Drug: Placebo
Placebo tablets taken orally once per day for 6 months
Other Name: Corn oil placebo

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729430

Locations
United States, Massachusetts
Brigham and Women's Hospital, Shapiro Cardiovascular Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Investigators
Principal Investigator: Raymond Y. Kwong, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Raymond Y. Kwong, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00729430     History of Changes
Other Study ID Numbers: 591
R01HL091157-01 ( U.S. NIH Grant/Contract )
Study First Received: August 4, 2008
Results First Received: February 28, 2017
Last Updated: May 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data with GISSI Heart Failure group for pooling and meta-analysis

Keywords provided by Raymond Y. Kwong, MD, Brigham and Women's Hospital:
Heart Attack
Sudden Cardiac Death
Peri-infarct Zone
Omega-3 Fatty Acids
Biological Markers
Cytogenetic Analysis
Cardiac Arrest

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Death, Sudden
Death, Sudden, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Death
Heart Arrest

ClinicalTrials.gov processed this record on July 21, 2017