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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.
Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality. Atrial fibrillation is also associated with an increased risk for strokes, use of potentially harmful drugs, and the need for pacemaker therapy.
This study is for patients who are undergoing elective bypass surgery. Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery, treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14 days, whichever is first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fish oil , corn oil | Experimental | Highly purified pharmaceutical grade omega three polyunsaturated fatty acids |
|
| placebo | Placebo Comparator | olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega Three Polyunsaturated fatty acids | Drug | 2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Postoperative Atrial Fibrillation | The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chirag M Sandesara, MD | Virginia Cardiovascular Associates | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23130134 | Derived | Sandesara CM, Chung MK, Van Wagoner DR, Barringer TA, Allen K, Ismail HM, Zimmerman B, Olshansky B. A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids for Inhibition of Supraventricular Arrhythmias After Cardiac Surgery: The FISH Trial. J Am Heart Assoc. 2012 Jun;1(3):e000547. doi: 10.1161/JAHA.111.000547. Epub 2012 Jun 22. |
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The recruitment period was from February 2007 to December 2009. Patients were recruited from cardiothoracic clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil | Highly purified pharmaceutical grade omega three polyunsaturated fatty acids |
| FG001 | Corn Oil |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fish Oil | Highly purified pharmaceutical grade omega three polyunsaturated fatty acids |
| BG001 | Corn Oil | Standard grade corn oil |
| 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 | Number of Participants Who Developed Postoperative Atrial Fibrillation | The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment. | Intention to treat | Posted | Number | participants | 14 days |
|
|
1 year
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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 | Fish Oil | Highly purified pharmaceutical grade omega three polyunsaturated fatty acids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Chirag Sandesara | Carient Heart and Vascular | 7033358750 | csandesara@carient.org |
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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 |
|---|---|
| C405603 | Omacor |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | Corn Oil | Standard corn oil | 0 | 130 | 0 | 130 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |