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| Name | Class |
|---|---|
| The OPERA Investigators | UNKNOWN |
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This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 fatty acid capsules | Experimental |
| |
| Olive Oil capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega -3 fatty acids | Drug | 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Any First Post-op Atrial Fibrillation or Flutter (AF) | Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics). | up to 10 days post-surgery or discharge, whichever sooner |
| Measure | Description | Time Frame |
|---|---|---|
| Post-op Af | Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dariush Mozaffarian, MD DrPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Roberto Marchioli, MD | Laboratory of Clinical Epidemiology of Cardiovascular Disease Department of Clinical Pharmacology and Epidemiology Consorzio Mario Negri Sud Via Nazionale 8/A S. Maria Imbaro (Chieti), 66030 ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US, Italy and Argentina | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30571332 | Derived | Akintoye E, Sethi P, Harris WS, Thompson PA, Marchioli R, Tavazzi L, Latini R, Pretorius M, Brown NJ, Libby P, Mozaffarian D. Fish Oil and Perioperative Bleeding. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004584. doi: 10.1161/CIRCOUTCOMES.118.004584. | |
| 29546292 | Derived | Jackson JC, Mozaffarian D, Graves AJ, Brown NJ, Marchioli R, Kiehl AL, Ely EW. Fish Oil Supplementation Does Not Affect Cognitive Outcomes in Cardiac Surgery Patients in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial. J Nutr. 2018 Mar 1;148(3):472-479. doi: 10.1093/jn/nxx002. |
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Ineligible patients were most often excluded because they were not in sinus rhythm (40.5%), were on fish oil (28.9%), or were unwilling to provide informed consent (23.5%).
A total of 1,516 patients scheduled for cardiac surgery (CS) across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. 48% of screened patients and 94% of eligible patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olive Oil Capsule | Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center. Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules). Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner. |
| FG001 | Omega-3 Fatty Acid Capsules | Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients scheduled for cardiac surgery across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Forty-eight percent of screened patients and 94% of eligible patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Olive Oil Capsule | Placebo : Olive Oil capsules |
| BG001 | Omega-3 Fatty Acid Capsules | Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first. |
| 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 | Any First Post-op Atrial Fibrillation or Flutter (AF) | Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics). | Posted | Number | Participants | up to 10 days post-surgery or discharge, whichever sooner |
|
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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 | Olive Oil Capsule | Placebo : Olive Oil capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow or coagulation | Blood and lymphatic system disorders |
Best-practice guidelines for preventing post-op atrial fibrillation were recommended to Centers. The duration prior to surgery may have been too short to be effective; or the dose of n-3 PUFA too low to produce benefit
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Namasha Schelling | Harvard School of Public Health | 617-432-1734 | nschelling@hsph.harvard.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo | Drug | Olive Oil capsules |
|
| up to 10 days post-surgery or discharge, whichever sooner |
| Other Arrhythmias |
| up to 10 days post-surgery or discharge, whichever sooner |
| Other Endpoints |
| up to 10 days post-surgery or discharge, whichever sooner |
| 25994442 | Derived | Wu JH, Marchioli R, Silletta MG, Masson S, Sellke FW, Libby P, Milne GL, Brown NJ, Lombardi F, Damiano RJ Jr, Marsala J, Rinaldi M, Domenech A, Simon C, Tavazzi L, Mozaffarian D. Oxidative Stress Biomarkers and Incidence of Postoperative Atrial Fibrillation in the Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) Trial. J Am Heart Assoc. 2015 May 20;4(5):e001886. doi: 10.1161/JAHA.115.001886. |
| 24145742 | Derived | Wu JH, Marchioli R, Silletta MG, Macchia A, Song X, Siscovick DS, Harris WS, Masson S, Latini R, Albert C, Brown NJ, Lamarra M, Favaloro RR, Mozaffarian D. Plasma phospholipid omega-3 fatty acids and incidence of postoperative atrial fibrillation in the OPERA trial. J Am Heart Assoc. 2013 Oct 21;2(5):e000397. doi: 10.1161/JAHA.113.000397. |
| 23128104 | Derived | Mozaffarian D, Marchioli R, Macchia A, Silletta MG, Ferrazzi P, Gardner TJ, Latini R, Libby P, Lombardi F, O'Gara PT, Page RL, Tavazzi L, Tognoni G; OPERA Investigators. Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial. JAMA. 2012 Nov 21;308(19):2001-11. doi: 10.1001/jama.2012.28733. |
| 21742090 | Derived | Mozaffarian D, Marchioli R, Gardner T, Ferrazzi P, O'Gara P, Latini R, Libby P, Lombardi F, Macchia A, Page R, Santini M, Tavazzi L, Tognoni G. The omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design. Am Heart J. 2011 Jul;162(1):56-63.e3. doi: 10.1016/j.ahj.2011.03.035. Epub 2011 Jun 12. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Post-op Af | Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality. | Posted | Number | Participants | up to 10 days post-surgery or discharge, whichever sooner |
|
|
|
| Secondary | Other Arrhythmias |
| Posted | Number | Participants | up to 10 days post-surgery or discharge, whichever sooner |
|
|
|
| Secondary | Other Endpoints |
| Posted | Number | Participants | up to 10 days post-surgery or discharge, whichever sooner |
|
|
|
| 147 |
| 758 |
| 20 |
| 758 |
| EG001 | Omega-3 Fatty Acid Capsules | Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first. | 136 | 758 | 19 | 758 |
| Bone marrow or coalgulation | Blood and lymphatic system disorders |
|
| Cardiac | Cardiac disorders |
|
| Constitutional symptoms | General disorders |
|
| Dermatology or musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Gastrointestinal, hepatobiliary, or pancreas | Gastrointestinal disorders |
|
| Infection | Immune system disorders |
|
| Metabolic or laboratory | Metabolism and nutrition disorders |
|
| Neurologic | Nervous system disorders |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders |
|
| Renal or genitourinary | Renal and urinary disorders |
|
| Vascular | Vascular disorders |
|
| Other | General disorders |
|
| Bleeding | Blood and lymphatic system disorders |
|
| Cardiac | Cardiac disorders |
|
| Constitutional symptoms | General disorders |
|
| Dermatology or musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Gastrointestinal, hepatobiliary, or pancreas | Gastrointestinal disorders |
|
| Infection | Immune system disorders |
|
| Metabolic or laboratory | Metabolism and nutrition disorders |
|
| Neurologic | Nervous system disorders |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders |
|
| Renal or genitourinary | Renal and urinary disorders |
|
| Vascular | Vascular disorders |
|
| Other | General disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |