Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

Study Overview
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Brief Summary
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The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.

Detailed Description
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In this 2:1 double-blind, randomized, placebo controlled trial, subjects will be given an active drug of n-3 polyunsaturated fatty acids (PUFAs) or a placebo soybean oil for about two weeks prior to an endovascular abdominal aortic repair (EVAR) and subsequently six months after the procedure. An EVAR is known to produce a systemic inflammatory response with an increased risk of prolonged hospitalization and complicated post-operative recovery with cardiac events, renal and pulmonary dysfunction, and multiple organ failure. The study proposed here has the potential to provide valuable insight on the role of nutritional intervention to improve outcomes related to surgical revascularization.

Official Title
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Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.

Conditions
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PAD, Abdominal Aortic Aneurysm

Intervention / Treatment
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* Dietary Supplement: Pro-Omega
* Other: ProOmega Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm Exclusion Criteria: Age < 40 or > 90 years On dual antiplatelet therapy or anticoagulation Evidence of active infection Diagnosed hypercoagulable state Non-atherosclerotic/aneurysmal disease as indication for procedure Chronic liver disease or myopathy End-stage renal disease (CKD 5) Poorly controlled diabetes (HbA1C > 8%) Recent other major surgery or illness within 6 weeks Use of immunosuppressive medication or extant chronic inflammatory disorders History of organ transplantation Pregnancy or plans to become pregnant Condition in which patient life expectancy is less than one year Known allergy to fish or fish products Presence of symptomatic or ruptured AAA

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pro-Omega<br>High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA) | Dietary Supplement: Pro-Omega<br>* Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.<br>|
| Placebo Comparator: Placebo<br>Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months | Other: ProOmega Placebo<br>* Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highly Sensitive C-Reactive Protein | Blunting of the peri-PVI inflammatory response as measured by the area under the curve (AUC) of the inflammatory biomarker high sensitivity C reactive protein (CRP) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Inflammatory Markers | Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes. | 6 months |