Summary

for people ages 40-90 (full criteria)
at San Francisco, California
study started
estimated completion
Warren Gasper, M.D

Description

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.

Official Title

Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.

Details

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.

Keywords

PAD Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Inflammation Pro-Omega

Eligibility

You can join if…

Open to people ages 40-90

  • Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm

You CAN'T join if...

  • 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

Location

  • San Francisco Veteran Affairs Medical Center
    San Francisco California 94121 United States

Lead Scientist

  • Warren Gasper, M.D
    My current research interests fall broadly into the categories of vein / vein graft physiology and advanced endovascular aneurysm therapies.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03208920
Study Type
Interventional
Last Updated