PADOmega-EVARNCT03208920
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
A study testing Pro-Omega in people with PAD and Abdominal Aortic Aneurysm, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- PAD, Abdominal Aortic Aneurysm
- What is being tested?
- Pro-Omega
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veteran Affairs Medical Center
San Francisco, California, 94121
About this study
Official title: Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
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.
Read the 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.
- Conditions
- PAD, Abdominal Aortic Aneurysm
- Being tested
- Pro-Omega, ProOmega Placebo
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-OmegaDietary supplement
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.
ProOmega PlaceboOther
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pro-Omega | Experimental | High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA) Receives: Dietary Supplement: Pro-Omega |
| Placebo | Placebo comparator | Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months Receives: Other: ProOmega Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study startDec 2016
- Primary completion28 Mar 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for PADStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren Gasper, M.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208920
- Sponsor's protocol ID
- 15-16505
- Acronym
- Omega-EVAR
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2017
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Galle C, De Maertelaer V, Motte S, Zhou L, Stordeur P, Delville JP, Li R, Ferreira J, Goldman M, Capel P, Wautrecht JC, Pradier O, Dereume JP. Early inflammatory response after elective abdominal aortic aneurysm repair: a comparison between endovascular procedure and conventional surgery. J Vasc Surg. 2000 Aug;32(2):234-46. doi: 10.1067/mva.2000.107562.
PubMed 10917982Serhan CN, Brain SD, Buckley CD, Gilroy DW, Haslett C, O'Neill LA, Perretti M, Rossi AG, Wallace JL. Resolution of inflammation: state of the art, definitions and terms. FASEB J. 2007 Feb;21(2):325-32. doi: 10.1096/fj.06-7227rev.
PubMed 17267386Serhan CN, Chiang N, Van Dyke TE. Resolving inflammation: dual anti-inflammatory and pro-resolution lipid mediators. Nat Rev Immunol. 2008 May;8(5):349-61. doi: 10.1038/nri2294.
PubMed 18437155Serhan CN, Hong S, Gronert K, Colgan SP, Devchand PR, Mirick G, Moussignac RL. Resolvins: a family of bioactive products of omega-3 fatty acid transformation circuits initiated by aspirin treatment that counter proinflammation signals. J Exp Med. 2002 Oct 21;196(8):1025-37. doi: 10.1084/jem.20020760.
PubMed 12391014Spite M, Serhan CN. Novel lipid mediators promote resolution of acute inflammation: impact of aspirin and statins. Circ Res. 2010 Nov 12;107(10):1170-84. doi: 10.1161/CIRCRESAHA.110.223883.
PubMed 21071715Serhan CN. Resolution phase of inflammation: novel endogenous anti-inflammatory and proresolving lipid mediators and pathways. Annu Rev Immunol. 2007;25:101-37. doi: 10.1146/annurev.immunol.25.022106.141647.
PubMed 17090225Serhan CN, Yang R, Martinod K, Kasuga K, Pillai PS, Porter TF, Oh SF, Spite M. Maresins: novel macrophage mediators with potent antiinflammatory and proresolving actions. J Exp Med. 2009 Jan 16;206(1):15-23. doi: 10.1084/jem.20081880. Epub 2008 Dec 22.
PubMed 19103881Ho KJ, Spite M, Owens CD, Lancero H, Kroemer AH, Pande R, Creager MA, Serhan CN, Conte MS. Aspirin-triggered lipoxin and resolvin E1 modulate vascular smooth muscle phenotype and correlate with peripheral atherosclerosis. Am J Pathol. 2010 Oct;177(4):2116-23. doi: 10.2353/ajpath.2010.091082. Epub 2010 Aug 13.
PubMed 20709806Grenon 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.
PubMed 23830313Wang JH, Eguchi K, Matsumoto S, Fujiu K, Komuro I, Nagai R, Manabe I. The omega-3 polyunsaturated fatty acid, eicosapentaenoic acid, attenuates abdominal aortic aneurysm development via suppression of tissue remodeling. PLoS One. 2014 May 5;9(5):e96286. doi: 10.1371/journal.pone.0096286. eCollection 2014.
PubMed 24798452Velazquez OC, Carpenter JP, Baum RA, Barker CF, Golden M, Criado F, Pyeron A, Fairman RM. Perigraft air, fever, and leukocytosis after endovascular repair of abdominal aortic aneurysms. Am J Surg. 1999 Sep;178(3):185-9. doi: 10.1016/s0002-9610(99)00144-0.
PubMed 10527435Storck M, Scharrer-Pamler R, Kapfer X, Gallmeier U, Gorich J, Sunder-Plassmann L, Bruckner U, Mickley V. Does a postimplantation syndrome following endovascular treatment of aortic aneurysms exist? Vasc Surg. 2001 Jan-Feb;35(1):23-9. doi: 10.1177/153857440103500105.
PubMed 11668365Rizas KD, Ippagunta N, Tilson MD 3rd. Immune cells and molecular mediators in the pathogenesis of the abdominal aortic aneurysm. Cardiol Rev. 2009 Sep-Oct;17(5):201-10. doi: 10.1097/CRD.0b013e3181b04698.
PubMed 19690470Lindeman JH, Abdul-Hussien H, Schaapherder AF, Van Bockel JH, Von der Thusen JH, Roelen DL, Kleemann R. Enhanced expression and activation of pro-inflammatory transcription factors distinguish aneurysmal from atherosclerotic aorta: IL-6- and IL-8-dominated inflammatory responses prevail in the human aneurysm. Clin Sci (Lond). 2008 Jun;114(11):687-97. doi: 10.1042/CS20070352.
PubMed 18078385Zimmer S, Heiss MM, Schardey HM, Weilbach C, Faist E, Lauterjung L. [Inflammatory syndrome after endovascular implantation of an aortic stent--a comparative study]. Langenbecks Arch Chir Suppl Kongressbd. 1998;115(Suppl I):13-7. German.
PubMed 14518202
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
- ClinicalTrials.gov ID
- NCT03208920
- Acronym / sponsor ID
- Omega-EVAR / 15-16505
- Conditions
- PAD, Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro-Omega | Experimental | Dietary Supplement: Pro-OmegaHigh-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA) |
| Placebo | Placebo comparator | Other: ProOmega PlaceboPro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-OmegaPro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months. | Dietary supplement | Pro-Omega |
| ProOmega PlaceboPlacebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months. | Other | Placebo |
Primary outcome
Highly Sensitive C-Reactive Protein
Time frame: 6 months
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)
1 secondary outcome
Systemic Inflammatory Markers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Background: PubMed 10917982Galle C, De Maertelaer V, Motte S, Zhou L, Stordeur P, Delville JP, Li R, Ferreira J, Goldman M, Capel P, Wautrecht JC, Pradier O, Dereume JP. Early inflammatory response after elective abdominal aortic aneurysm repair: a comparison between endovascular procedure and conventional surgery. J Vasc Surg. 2000 Aug;32(2):234-46. doi: 10.1067/mva.2000.107562.
- Background: PubMed 17267386Serhan CN, Brain SD, Buckley CD, Gilroy DW, Haslett C, O'Neill LA, Perretti M, Rossi AG, Wallace JL. Resolution of inflammation: state of the art, definitions and terms. FASEB J. 2007 Feb;21(2):325-32. doi: 10.1096/fj.06-7227rev.
- Background: PubMed 18437155Serhan CN, Chiang N, Van Dyke TE. Resolving inflammation: dual anti-inflammatory and pro-resolution lipid mediators. Nat Rev Immunol. 2008 May;8(5):349-61. doi: 10.1038/nri2294.
- Background: PubMed 12391014Serhan CN, Hong S, Gronert K, Colgan SP, Devchand PR, Mirick G, Moussignac RL. Resolvins: a family of bioactive products of omega-3 fatty acid transformation circuits initiated by aspirin treatment that counter proinflammation signals. J Exp Med. 2002 Oct 21;196(8):1025-37. doi: 10.1084/jem.20020760.
- Background: PubMed 21071715Spite M, Serhan CN. Novel lipid mediators promote resolution of acute inflammation: impact of aspirin and statins. Circ Res. 2010 Nov 12;107(10):1170-84. doi: 10.1161/CIRCRESAHA.110.223883.
- Background: PubMed 17090225Serhan CN. Resolution phase of inflammation: novel endogenous anti-inflammatory and proresolving lipid mediators and pathways. Annu Rev Immunol. 2007;25:101-37. doi: 10.1146/annurev.immunol.25.022106.141647.
- Background: PubMed 19103881Serhan CN, Yang R, Martinod K, Kasuga K, Pillai PS, Porter TF, Oh SF, Spite M. Maresins: novel macrophage mediators with potent antiinflammatory and proresolving actions. J Exp Med. 2009 Jan 16;206(1):15-23. doi: 10.1084/jem.20081880. Epub 2008 Dec 22.
- Background: PubMed 20709806Ho KJ, Spite M, Owens CD, Lancero H, Kroemer AH, Pande R, Creager MA, Serhan CN, Conte MS. Aspirin-triggered lipoxin and resolvin E1 modulate vascular smooth muscle phenotype and correlate with peripheral atherosclerosis. Am J Pathol. 2010 Oct;177(4):2116-23. doi: 10.2353/ajpath.2010.091082. Epub 2010 Aug 13.
- Background: PubMed 23830313Grenon 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.
- Background: PubMed 24798452Wang JH, Eguchi K, Matsumoto S, Fujiu K, Komuro I, Nagai R, Manabe I. The omega-3 polyunsaturated fatty acid, eicosapentaenoic acid, attenuates abdominal aortic aneurysm development via suppression of tissue remodeling. PLoS One. 2014 May 5;9(5):e96286. doi: 10.1371/journal.pone.0096286. eCollection 2014.
- Background: PubMed 10527435Velazquez OC, Carpenter JP, Baum RA, Barker CF, Golden M, Criado F, Pyeron A, Fairman RM. Perigraft air, fever, and leukocytosis after endovascular repair of abdominal aortic aneurysms. Am J Surg. 1999 Sep;178(3):185-9. doi: 10.1016/s0002-9610(99)00144-0.
- Background: PubMed 11668365Storck M, Scharrer-Pamler R, Kapfer X, Gallmeier U, Gorich J, Sunder-Plassmann L, Bruckner U, Mickley V. Does a postimplantation syndrome following endovascular treatment of aortic aneurysms exist? Vasc Surg. 2001 Jan-Feb;35(1):23-9. doi: 10.1177/153857440103500105.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Gasper, M.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-Omega in people with PAD and Abdominal Aortic Aneurysm, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highly Sensitive C-Reactive Protein (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208920, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.