Bobak Heydari1, Shuaib Abdullah1, James V Pottala1, Ravi Shah1, Siddique Abbasi1, Damien Mandry1, Sanjeev A Francis1, Heidi Lumish1, Brian B Ghoshhajra1, Udo Hoffmann1, Evan Appelbaum1, Jiazhuo H Feng1, Ron Blankstein1, Michael Steigner1, Joseph P McConnell1, William Harris1, Elliott M Antman1, Michael Jerosch-Herold1, Raymond Y Kwong2. 1. From Noninvasive Cardiovascular Imaging Section, Cardiovascular Division, Department of Medicine and Department of Radiology, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., R.B., M.S., M.J.-H., R.Y.K.); Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., E.M.A., R.Y.K.); Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Fall (J.V.P., W.H.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (R.S., S.A.F.); Department of Radiology, Massachusetts General Hospital, Boston (H.L., B.B.G., U.F.); Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.); Health Diagnostic Laboratory, Inc., Richmond, VA (J.P.M.); and OmegaQuant Analytics, LLC, Sioux Falls, SD (W.H.). 2. From Noninvasive Cardiovascular Imaging Section, Cardiovascular Division, Department of Medicine and Department of Radiology, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., R.B., M.S., M.J.-H., R.Y.K.); Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., E.M.A., R.Y.K.); Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Fall (J.V.P., W.H.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (R.S., S.A.F.); Department of Radiology, Massachusetts General Hospital, Boston (H.L., B.B.G., U.F.); Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.); Health Diagnostic Laboratory, Inc., Richmond, VA (J.P.M.); and OmegaQuant Analytics, LLC, Sioux Falls, SD (W.H.). rykwong@partners.org.
Abstract
BACKGROUND:Omega-3 fatty acids from fish oil have been associated with beneficial cardiovascular effects, but their role in modifying cardiac structures and tissue characteristics in patients who have had an acute myocardial infarction while receiving current guideline-based therapy remains unknown. METHODS: In a multicenter, double-blind, placebo-controlled trial, participants presenting with an acute myocardial infarction were randomly assigned 1:1 to 6 months of high-dose omega-3 fatty acids (n=180) or placebo (n=178). Cardiac magnetic resonance imaging was used to assess cardiac structure and tissue characteristics at baseline and after study therapy. The primary study endpoint was change in left ventricular systolic volume index. Secondary endpoints included change in noninfarct myocardial fibrosis, left ventricular ejection fraction, and infarct size. RESULTS: By intention-to-treat analysis, patients randomly assigned to omega-3 fatty acids experienced a significant reduction of left ventricular systolic volume index (-5.8%, P=0.017), and noninfarct myocardial fibrosis (-5.6%, P=0.026) in comparison with placebo. Per-protocol analysis revealed that those patients who achieved the highest quartile increase in red blood cell omega-3 index experienced a 13% reduction in left ventricular systolic volume index in comparison with the lowest quartile. In addition, patients in the omega-3 fatty acid arm underwent significant reductions in serum biomarkers of systemic and vascular inflammation and myocardial fibrosis. There were no adverse events associated with high-dose omega-3 fatty acid therapy. CONCLUSIONS: Treatment of patients with acute myocardial infarction with high-doseomega-3 fatty acids was associated with reduction of adverse left ventricular remodeling, noninfarct myocardial fibrosis, and serum biomarkers of systemic inflammation beyond current guideline-based standard of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729430.
RCT Entities:
BACKGROUND:Omega-3 fatty acids from fish oil have been associated with beneficial cardiovascular effects, but their role in modifying cardiac structures and tissue characteristics in patients who have had an acute myocardial infarction while receiving current guideline-based therapy remains unknown. METHODS: In a multicenter, double-blind, placebo-controlled trial, participants presenting with an acute myocardial infarction were randomly assigned 1:1 to 6 months of high-dose omega-3 fatty acids (n=180) or placebo (n=178). Cardiac magnetic resonance imaging was used to assess cardiac structure and tissue characteristics at baseline and after study therapy. The primary study endpoint was change in left ventricular systolic volume index. Secondary endpoints included change in noninfarct myocardial fibrosis, left ventricular ejection fraction, and infarct size. RESULTS: By intention-to-treat analysis, patients randomly assigned to omega-3 fatty acids experienced a significant reduction of left ventricular systolic volume index (-5.8%, P=0.017), and noninfarct myocardial fibrosis (-5.6%, P=0.026) in comparison with placebo. Per-protocol analysis revealed that those patients who achieved the highest quartile increase in red blood cell omega-3 index experienced a 13% reduction in left ventricular systolic volume index in comparison with the lowest quartile. In addition, patients in the omega-3 fatty acid arm underwent significant reductions in serum biomarkers of systemic and vascular inflammation and myocardial fibrosis. There were no adverse events associated with high-dose omega-3 fatty acid therapy. CONCLUSIONS: Treatment of patients with acute myocardial infarction with high-dose omega-3 fatty acids was associated with reduction of adverse left ventricular remodeling, noninfarct myocardial fibrosis, and serum biomarkers of systemic inflammation beyond current guideline-based standard of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729430.
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