Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging (OmegaREMODEL)
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ClinicalTrials.gov Identifier: NCT00729430 |
Recruitment Status
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Completed
First Posted
: August 7, 2008
Results First Posted
: June 1, 2017
Last Update Posted
: June 1, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | August 4, 2008 | ||||
First Posted Date ICMJE | August 7, 2008 | ||||
Results First Submitted Date | February 28, 2017 | ||||
Results First Posted Date | June 1, 2017 | ||||
Last Update Posted Date | June 1, 2017 | ||||
Study Start Date ICMJE | August 2008 | ||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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)
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Original Primary Outcome Measures ICMJE |
Predictive value of peri-infarct zone on sudden cardiac death [ Time Frame: 5 Years ] | ||||
Change History | Complete list of historical versions of study NCT00729430 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Effect of Omega-3 fatty acids on Sudden Cardiac Death post STEMI [ Time Frame: 5 years ] | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging | ||||
Official Title ICMJE | Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
358 | ||||
Original Estimated Enrollment ICMJE |
414 | ||||
Actual Study Completion Date | July 2014 | ||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00729430 | ||||
Other Study ID Numbers ICMJE | 591 R01HL091157-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Raymond Y. Kwong, MD, Brigham and Women's Hospital | ||||
Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Brigham and Women's Hospital | ||||
Verification Date | May 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |