- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03208920
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair (Omega-EVAR)
Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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San Francisco, California, Förenta staterna, 94121
- San Francisco Veteran Affairs Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)
|
Pro-Omega (Nordic Naturals, Watsonville, CA, USA).
Each Pro-Omega capsule is 550 mg.
Must take 4400 mg/day x 6 months.
|
Placebo-jämförare: Placebo
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months
|
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA).
Each soybean capsule is 550 mg.
Must take 4400 mg/day x 6 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Highly Sensitive C-Reactive Protein
Tidsram: 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)
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Systemic Inflammatory Markers
Tidsram: 6 months
|
Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
|
6 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Warren Gasper, M.D, University of California, San Francisco
Publikationer och användbara länkar
Allmänna publikationer
- Tang Y, Zhang MJ, Hellmann J, Kosuri M, Bhatnagar A, Spite M. Proresolution therapy for the treatment of delayed healing of diabetic wounds. Diabetes. 2013 Feb;62(2):618-27. doi: 10.2337/db12-0684. Epub 2012 Oct 5.
- 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.
- Serhan 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.
- Serhan 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.
- Serhan 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.
- Spite 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.
- Serhan 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.
- Serhan 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.
- Ho 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.
- Grenon 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.
- Wang 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.
- Velazquez 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.
- Storck 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.
- Rizas 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.
- Lindeman 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.
- Zimmer 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.
- Boyle JR, Goodall S, Thompson JP, Bell PR, Thompson MM. Endovascular AAA repair attenuates the inflammatory and renal responses associated with conventional surgery. J Endovasc Ther. 2000 Oct;7(5):359-71. doi: 10.1177/152660280000700503.
- Chang CK, Chuter TA, Niemann CU, Shlipak MG, Cohen MJ, Reilly LM, Hiramoto JS. Systemic inflammation, coagulopathy, and acute renal insufficiency following endovascular thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2009 May;49(5):1140-6. doi: 10.1016/j.jvs.2008.11.102.
- Moulakakis KG, Alepaki M, Sfyroeras GS, Antonopoulos CN, Giannakopoulos TG, Kakisis J, Karakitsos P, Liapis CD. The impact of endograft type on inflammatory response after endovascular treatment of abdominal aortic aneurysm. J Vasc Surg. 2013 Mar;57(3):668-77. doi: 10.1016/j.jvs.2012.09.034. Epub 2013 Jan 11.
- Morikage N, Esato K, Zenpo N, Fujioka K, Takenaka H. Is endovascular treatment of abdominal aortic aneurysms less invasive regarding the biological responses? Surg Today. 2000;30(2):142-6. doi: 10.1007/PL00010062.
- Swartbol P, Truedsson L, Norgren L. Adverse reactions during endovascular treatment of aortic aneurysms may be triggered by interleukin 6 release from the thrombotic content. J Vasc Surg. 1998 Oct;28(4):664-8. doi: 10.1016/s0741-5214(98)70092-8.
- Gerasimidis T, Sfyroeras G, Trellopoulos G, Skoura L, Papazoglou K, Konstantinidis K, Karamanos D, Filaktou A, Parapanisiou E. Impact of endograft material on the inflammatory response after elective endovascular abdominal aortic aneurysm repair. Angiology. 2005 Nov-Dec;56(6):743-53. doi: 10.1177/000331970505600612.
- Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276.
- Bannenberg GL, Chiang N, Ariel A, Arita M, Tjonahen E, Gotlinger KH, Hong S, Serhan CN. Molecular circuits of resolution: formation and actions of resolvins and protectins. J Immunol. 2005 Apr 1;174(7):4345-55. doi: 10.4049/jimmunol.174.7.4345. Erratum In: J Immunol. 2005 May 1;174(9):5884.
- Serhan CN, Clish CB, Brannon J, Colgan SP, Chiang N, Gronert K. Novel functional sets of lipid-derived mediators with antiinflammatory actions generated from omega-3 fatty acids via cyclooxygenase 2-nonsteroidal antiinflammatory drugs and transcellular processing. J Exp Med. 2000 Oct 16;192(8):1197-204. doi: 10.1084/jem.192.8.1197.
- Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27.
- Yang R, Chiang N, Oh SF, Serhan CN. Metabolomics-lipidomics of eicosanoids and docosanoids generated by phagocytes. Curr Protoc Immunol. 2011 Nov;Chapter 14:Unit 14.26. doi: 10.1002/0471142735.im1426s95.
- Harris WS. The omega-3 index as a risk factor for coronary heart disease. Am J Clin Nutr. 2008 Jun;87(6):1997S-2002S. doi: 10.1093/ajcn/87.6.1997S.
- Freidlin B, Korn EL, George SL. Data monitoring committees and interim monitoring guidelines. Control Clin Trials. 1999 Oct;20(5):395-407. doi: 10.1016/s0197-2456(99)00017-3.
- Whitehead J. Monitoring and evaluating clinical trials data. Intensive Care Med. 2000;26 Suppl 1:S84-8. doi: 10.1007/s001340051123.
- Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA. 2001 Mar 7;285(9):1201-5. doi: 10.1001/jama.285.9.1201.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15-16505
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