The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Study Overview
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Brief Summary
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Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).

Detailed Description
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The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.

Official Title
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The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Conditions
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Peripheral Arterial Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disabling claudication or CLI as indication for PVI (Rutherford Class II-V) Objective evidence of PAD e.g. ABI < 0.9, TBI < 0.6 or absent pedal pulses Currently not taking high-dose n-3 PUFA, as defined by >2 g/day Able to provide written informed consent AND Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery. Exclusion Criteria: Age < 40 or > 90 years Undergoing open surgical revascularization Evidence of active infection in limb or foot or osteomyelitis Extensive tissue loss (Rutherford Class VI Disease) 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 immunosuppressives or chronic inflammatory disorders History of organ transplantation Pregnancy or plans to become pregnant Condition in which patient life expectancy is less than one year

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Pro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after. | Other: Pro-Omega Placebo<br>* Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after<br>|
| Experimental: Pro-Omega<br>High-dose, short-duration dietary omega-3 fatty acids supplementation; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after. | Dietary Supplement: Pro-Omega<br>* Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after<br>* Other names: Fish Oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Inflammatory bio-markers | Will 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | We hypothesize that n-3 PUFA supplementation in the peri-PVI period will be safe and will not lead to an increase in adverse events including bleeding and pseudoaneurysm formation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Claudication, Critical Limb Ischemia, Endovascular procedure, Atherosclerosis