The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

Abstract Background Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized...

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Autores principales:	Ana I. Fernández, Javier Bermejo, Raquel Yotti, Miguel Ángel Martínez-Gonzalez, Alex Mira, Uri Gophna, Roger Karlsson, Reem Al-Daccak, Irene Martín-Demiguel, Enrique Gutiérrez-Ibanes, Dominique Charron, Francisco Fernández-Avilés, on behalf of the MEDIMACS research team
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Atherosclerosis Mediterranean diet Immune system Microbiota -Omics Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/2d6a288246954eadafd789db954a6cae
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spelling	oai:doaj.org-article:2d6a288246954eadafd789db954a6cae2021-11-14T12:31:25ZThe impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial10.1186/s13063-021-05746-z1745-6215https://doaj.org/article/2d6a288246954eadafd789db954a6cae2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05746-zhttps://doaj.org/toc/1745-6215Abstract Background Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression. Methods The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints. Discussion The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS. Trial registration ClinicalTrials.gov NCT03842319 . Registered on 13 May 2019Ana I. FernándezJavier BermejoRaquel YottiMiguel Ángel Martínez-GonzalezAlex MiraUri GophnaRoger KarlssonReem Al-DaccakIrene Martín-DemiguelEnrique Gutiérrez-IbanesDominique CharronFrancisco Fernández-Aviléson behalf of the MEDIMACS research teamBMCarticleAtherosclerosisMediterranean dietImmune systemMicrobiota-OmicsRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Atherosclerosis Mediterranean diet Immune system Microbiota -Omics Randomized controlled trial Medicine (General) R5-920
spellingShingle	Atherosclerosis Mediterranean diet Immune system Microbiota -Omics Randomized controlled trial Medicine (General) R5-920 Ana I. Fernández Javier Bermejo Raquel Yotti Miguel Ángel Martínez-Gonzalez Alex Mira Uri Gophna Roger Karlsson Reem Al-Daccak Irene Martín-Demiguel Enrique Gutiérrez-Ibanes Dominique Charron Francisco Fernández-Avilés on behalf of the MEDIMACS research team The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
description	Abstract Background Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression. Methods The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints. Discussion The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS. Trial registration ClinicalTrials.gov NCT03842319 . Registered on 13 May 2019
format	article
author	Ana I. Fernández Javier Bermejo Raquel Yotti Miguel Ángel Martínez-Gonzalez Alex Mira Uri Gophna Roger Karlsson Reem Al-Daccak Irene Martín-Demiguel Enrique Gutiérrez-Ibanes Dominique Charron Francisco Fernández-Avilés on behalf of the MEDIMACS research team
author_facet	Ana I. Fernández Javier Bermejo Raquel Yotti Miguel Ángel Martínez-Gonzalez Alex Mira Uri Gophna Roger Karlsson Reem Al-Daccak Irene Martín-Demiguel Enrique Gutiérrez-Ibanes Dominique Charron Francisco Fernández-Avilés on behalf of the MEDIMACS research team
author_sort	Ana I. Fernández
title	The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
title_short	The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
title_full	The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
title_fullStr	The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
title_full_unstemmed	The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial
title_sort	impact of mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the medimacs randomized, controlled, mechanistic clinical trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/2d6a288246954eadafd789db954a6cae
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The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

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