Evidence map›Paper›PMID 34772433›Full record

ArticleTrials2021

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.

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 and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03842319 (Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03842319 nacompletednot on this map

Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.

TypeinterventionalSponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)Ran2019 to 2022Enrolled100ConditionsAcute Coronary SyndromeArmsMicrobiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. The Role of the Microbiome and the Neurovascular Unit.The Surgical clinics of North America · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 5 countries.

Ana I FernándezDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Javier BermejoDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain. javier.bermejo@salud.madrid.org.
Raquel YottiDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Miguel Ángel Martínez-GonzalezDepartment of Preventive Medicine and Public Health, University of Navarra, IDISNA, CIBEROBN, Pamplona, Spain.
Alex MiraDepartment of Health and Genomics, Center for Advanced Research in Public Health, CSISP-FISABIO, and CIBERESP, Valencia, Spain.
Uri GophnaDepartment of Molecular Microbiology and Biotechnology, George S. Wise Faculty of Life Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel.
Roger KarlssonDepartment 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.
Reem Al-DaccakInstitut 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.
Irene Martín-DemiguelDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Enrique Gutiérrez-IbanesDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Dominique CharronInstitut 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.
Francisco Fernández-AvilésDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
MEDIMACS research team
Universidad Complutense de Madrid · ESCentro de Investigación en Red en Enfermedades Cardiovasculares · ESHospital General Universitario Gregorio Marañón · ESInserm · FRUniversity of Gothenburg · SEFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESTel Aviv University · ILHarvard University · USHôpital Saint-Louis · FRUniversidad de Navarra · ES

Funding

Agence Nationale de la Recherche INTIMIC-138H2020 European Research Council INTIMIC-138Instituto de Salud Carlos III INTIMIC-138Ministry of Science Research and Technology INTIMIC-138Svenska Forskningsrådet Formas INTIMIC-138
6 · The paper itself

Abstract

backgroundPrimary 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.

methodsThe 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 registrationClinicalTrials.gov NCT03842319 . Registered on 13 May 2019.

Indexed as

Acute Coronary SyndromeDiet, MediterraneanGastrointestinal MicrobiomePlaque, AtheroscleroticHumansInflammationProspective StudiesRandomized Controlled Trials as TopicTomography, Optical CoherenceAtherosclerosisImmune systemMediterranean dietMicrobiota-OmicsRandomized controlled trial

Identifiers

PMID34772433
PMCPMC8588729
OpenAlexW3135974626

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.