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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL091157-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Fatty Acids | Experimental | Participants will receive a highly purified form of omega-3 fatty acids for 6 months. |
|
| Placebo | Placebo Comparator | Participants will receive placebo for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids (Fish Oil Supplements) | Drug | 4 grams of omega-3 fatty acids taken orally once per day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis | Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Y. Kwong, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital, Shapiro Cardiovascular Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16801462 | Background | 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. | |
| 27482002 | Result | 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. |
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Plan to share data with GISSI Heart Failure group for pooling and meta-analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Omega-3 Fatty Acid Arm | Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months |
| FG001 | Placebo Arm | Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Omega-3 Fatty Acid Arm | Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Percent Change | Before and after study treatments |
|
Measured in the 3-year follow-up period after participant's last study visit
Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Omega-3 Fatty Acids Arm | Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction (Tongue Swelling) | Immune system disorders | Systematic Assessment | One omega-3 fatty acid treated patient experienced tongue swelling 1 month after enrollment that necessitated study drug termination, which resulted in resolution of the patient's symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fishy Taste in Mouth | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Y. Kwong, Director of Cardiac Magnetic Resonance Imaging | Brigham and Women's Hospital | 857-307-1960 | rykwong@partners.org |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D016757 | Death, Sudden, Cardiac |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| C405603 | Omacor |
| C023768 | halofantrine |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Drug | Placebo tablets taken orally once per day for 6 months |
|
|
Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months) |
| Measured in the 3-year follow-up period after participant's last study visit |
| Effect of Omega-3 Fatty Acids on Infarct Size | Measured as change in infarct size from baseline to post-treatment (6-months) | Measured in the 3-year follow-up period after participant's last study visit |
| 31948661 | Derived | 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. |
| 31532795 | 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. |
Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis | Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months) | Posted | Mean | Standard Deviation | Percent Change | Measured in the 3-year follow-up period after participant's last study visit |
|
|
|
| Secondary | Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction | Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months) | Posted | Mean | Standard Deviation | Percent Change | Measured in the 3-year follow-up period after participant's last study visit |
|
|
|
| Secondary | Effect of Omega-3 Fatty Acids on Infarct Size | Measured as change in infarct size from baseline to post-treatment (6-months) | Posted | Mean | Standard Deviation | Percent Change | Measured in the 3-year follow-up period after participant's last study visit |
|
|
|
| 1 |
| 180 |
| 18 |
| 180 |
| EG001 | Placebo Arm | Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months | 0 | 178 | 11 | 178 |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment | Clinically significant bleeding or drop in hematocrit levels. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003645 | Death, Sudden |
| D003643 | Death |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |