- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
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San Francisco, California, Estados Unidos, 94121
- San Francisco Veteran Affairs Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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.
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Highly Sensitive C-Reactive Protein
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Systemic Inflammatory Markers
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Warren Gasper, M.D, University of California, San Francisco
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-16505
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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