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Vascular & Endovascular Surgery »  Research »  Clinical Research »  Clinical Trials »  14-13123 (OMEGA-PVI)

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1/Phase 2 Interventional 40 - 90 Years University of California, San Francisco 14-13123
NCT02096757
 Ongoing but not enrolling patients

Study Design:

Principal Investigator

Trial 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).

Eligibility

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

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 11/17/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
 
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