Peripheral Arterial Disease
Conditions
Keywords
Claudication, Critical Limb Ischemia, Endovascular procedure, Atherosclerosis
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTPro-Omega
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
OTHERPro-Omega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Inflammatory bio-markers | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 6 months | We hypothesize that n-3 PUFA supplementation in the peri-PVI period will lead to an improvement in the primary patency of PVI at 6 months, as demonstrated by ultrasound (U/S). |
Countries
United States
Outcome results
None listed