Clinical trial NCT02096757: The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Official title: The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Claudication
Critical Limb Ischemia
Endovascular procedure
Atherosclerosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systemic Inflammatory bio-markers
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 6 months
Other outcomes:
measure: Primary patency
timeFrame: 6 months
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
Study officials:
affiliation: UCSF & SFVAMC
name: Warren Gasper, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175.
citation: Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27.
citation: Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2.
citation: Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.