Abdominal Aortic Aneurysm, PAD
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTPro-Omega
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.
OTHERProOmega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highly Sensitive C-Reactive Protein | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Inflammatory Markers | 6 months | Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes. |
Countries
United States
Outcome results
None listed