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
Por:
Fernández AI, Bermejo J, Yotti R, Martínez-Gonzalez MÁ, Mira A, Gophna U, Karlsson R, Al-Daccak R, Martín-Demiguel I, Gutiérrez-Ibanes E, Charron D, Fernández-Avilés F and MEDIMACS research team
Publicada:
12 nov 2021
Ahead of Print:
12 nov 2021
Resumen:
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.
Filiaciones:
Fernández AI:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain
Bermejo J:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Yotti R:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain
Martínez-Gonzalez MÁ:
Department of Preventive Medicine and Public Health, University of Navarra, IDISNA, CIBEROBN, Pamplona, Spain
Department of Nutrition, Harvard TH Chan School of Public Health, Boston, USA
:
Department of Health and Genomics, Center for Advanced Research in Public Health, CSISP-FISABIO, and CIBERESP, Valencia, Spain
Gophna U:
Department of Molecular Microbiology and Biotechnology, George S. Wise Faculty of Life Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel
Karlsson R:
Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy of the University of Gothenburg
Sweden Nanoxis Consulting AB
Centre for Antibiotic Resistance Research (CARe), University of Gothenburg, Gothenburg, Sweden
Al-Daccak R:
Institut National de la Santé et de la Recherche Médicale (INSERM) UMRS-97f, Université Paris-Diderot, HLA et Médecine, Labex Transplantex, Hôpital Saint-Louis, Paris, France
Martín-Demiguel I:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain
Gutiérrez-Ibanes E:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain
Charron D:
Institut National de la Santé et de la Recherche Médicale (INSERM) UMRS-97f, Université Paris-Diderot, HLA et Médecine, Labex Transplantex, Hôpital Saint-Louis, Paris, France
Fernández-Avilés F:
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain
gold, Green Published, Green Submitted, Gold, Green
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