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NCT Number: NCT03842319

Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome

In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial function in order to decipher complex interplays between diet, microbiome, immunological and metabolic responses and coronary atherosclerosis. The investigators will focus on patients after an episode of acute coronary syndrome and use state-of-the-art techniques to address atherosclerotic plaque composition and coronary endothelial function. A number of different -omic approaches will be used to address effector pathways. The insights provided by this study will allow identifying potential new dietary, microbiota and/or metabolic targets for the treatment of atherosclerosis

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

Coronary atherosclerosis is a leading cause of mortality and disability worldwide. Continuous efforts are needed to improve secondary prevention and understand the mechanism underlying disease progression. Based on primary prevention trials, a potential benefit of the Mediterranean diet after an acute coronary syndrome can be anticipated. The integrated microbiome-mediated/ immunologic and metabolic pathways by which the Mediterranean diet modifies cardiovascular risk remain mostly unknown. Intestinal and oral dysbiosis is involved in the pathogenesis of atherosclerosis and microbiome dynamics may account for some of the observed benefits of Mediterranean diet. The first objective of the trial is to evaluate the effects of a well-controlled Mediterranean diet intervention on atherosclerotic plaque vulnerability and coronary endothelial dysfunction after an episode of acute coronary syndrome. The second objective is to decipher the interplays among diet, microbiota, immunity and metabolism responsible for the observed effects. The investigators propose a randomized mechanistic clinical trial, using state-of-the-art efficacy read-outs. The multidisciplinary consortium includes highly experienced cardiologists, nutritionists and experts in translational research in immunology, microbiomics, genomics, proteomics, metabolomics and metagenomics. This study will provide valuable insights to identify potential microbiome therapeutic targets for coronary artery disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients undergoing cardiac catheterization for an acute coronary syndrome.
  • At least 1 non-causal lesion in a coronary segment with a stenosis diameter between 40-70% that will not be submitted to intervention during the revascularization procedure.
  • Disposition and possibility to modify the diet.
  • With the ability to track and answer questionnaires.
  • Signature of informed consent for the study

Exclusion criteria

  • TIMI score <3 in the injury
  • Reference lesion with diameter <2.0 mm
  • LV ejection fraction (EF) less than 45%.
  • Active systemic infection
  • Active periodontal disease
  • Chronic inflammatory disease
  • Active treatment with corticosteroids or immunomodulators
  • Renal insufficiency with glomerular filtration less than 30 mL / min
  • Severe hepatic insufficiency (liver cirrhosis in Child B or C stages).
  • Comorbidity with life expectancy of less than one year

Treatment and study plan

Microbiota analysis

Other

From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.

Immunological analysis

Other

A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry

Proteome analysis

Other

A study of host and microbiota proteome will be carried out from samples using mass spectrometry

Metabolome analysis

Other

A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods

Clinical evaluation

Other

Clinical evaluation including hemostasis and biochemical studies

Diet evaluation

Other

Biochemical analysis and questionaries for diet adherence and exercise registration

MedDiet

Other

The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (>40 g/d) for cooking and dressing dishes; b) consumption of >2 daily servings of vegetables; c) >2-3 daily serving of fresh fruits; d) >3 weekly servings of legumes; e) >3 weekly servings of fish or seafood; f) >1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses

Primary outcomes

  1. Fibrous cap thickness change

    Time frame: 12 months

    Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.

Secondary outcomes

  1. Endothelial dysfunction

    Time frame: 12 months

    Vascular endothelial function measured using a Doppler pressure guidewire

  2. Intestinal microbiota composition changes

    Time frame: 12 months

    Changes from baseline in intestinal microbiota will be analysed using the 16S rRNA target gene sequencing approach at 3 months, 6 months, 9 months and 12 months

  3. Oral microbiota composition changes

    Time frame: 12 months

    Changes from baseline in oral microbiota will be analysed using the 16S rRNA target gene sequencing approach at 3 months, 6 months, 9 months and 12 months

  4. Adaptive immune system status changes

    Time frame: 12 months

    Changes from baseline of adaptive immune cell lineages will be assessed dynamically using high performance cytometry at 3 months, 6 months, 9 months and 12 months

  5. Innate immune system status changes

    Time frame: 12 months

    Changes from baseline of innate immune cell lineages will be assessed dynamically using high performance cytometry at 3 months, 6 months, 9 months and 12 months

  6. Blood protein profiling changes

    Time frame: 12 months

    Changes from baseline of host protein-profiles from collected plasma samples will be analyzed for detection of biomarkers at 3 months, 6 months, 9 months and 12 months

  7. Faecal protein profiling changes

    Time frame: 12 months

    Changes from baseline of host protein-profiles from collected faces samples will be analyzed for detection of biomarkers at 3 months, 6 months, 9 months and 12 months

  8. Urine metabolome profiling changes

    Time frame: 12 months

    Changes from baseline of host metabolome profiles in urine will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months

  9. Blood metabolome profiling changes

    Time frame: 12 months

    Changes from baseline of host metabolome profiles in blood will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months

  10. Faecal metabolome profiling changes

    Time frame: 12 months

    Changes from baseline of metabolome profiles in faecal samples will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months

Sponsors and collaborators

Lead sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Other Gov

Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
  • Göteborg University
  • Hospital General Universitario Gregorio Marañon
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Tel Aviv University
  • University of Navarra

Registry information

Official study title

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

Acronym: MEDIMACS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2019
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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