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

NCT03208920 | Completed DMC

• 1 other identifier: 15-16505
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

PAD; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• Systemic Inflammatory Markers

  6 months

Study Arms (2)

Pro-Omega

EXPERIMENTAL

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

Dietary Supplement: Pro-Omega

Placebo

PLACEBO COMPARATOR

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

Other: ProOmega Placebo

Interventions

Pro-Omega DIETARY_SUPPLEMENT

Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.

Pro-Omega

ProOmega Placebo OTHER

Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco Veteran Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Warren Gasper, M.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: December 1, 2016
• Primary Completion: March 28, 2018
• Study Completion: August 28, 2018
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

US (1)