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Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair (Omega-EVAR)

Primary Purpose

PAD, Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pro-Omega
ProOmega Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAD

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Veteran Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pro-Omega

Placebo

Arm Description

High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)

Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months

Outcomes

Primary Outcome Measures

Highly Sensitive C-Reactive Protein
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 Outcome Measures

Systemic Inflammatory Markers
Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.

Full Information

First Posted
July 3, 2017
Last Updated
July 13, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03208920
Brief Title
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Acronym
Omega-EVAR
Official Title
Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD, Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pro-Omega
Arm Type
Experimental
Arm Description
High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Pro-Omega
Intervention Description
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.
Intervention Type
Other
Intervention Name(s)
ProOmega Placebo
Intervention Description
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
Primary Outcome Measure Information:
Title
Highly Sensitive C-Reactive Protein
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Systemic Inflammatory Markers
Description
Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Gasper, M.D
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veteran Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

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Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

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