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

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Other: Diet evaluation; Other: Microbiota analysis; Other: MedDiet; Other: Immunological analysis; Other: Proteome analysis; Other: Clinical evaluation; Other: Metabolome analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03842319

CIBER-MEDIMACS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control

Experimental group

Description:

In patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation

Treatment:

Other: Metabolome analysis

Other: Diet evaluation

Other: Immunological analysis

Other: Proteome analysis

Other: Clinical evaluation

Other: Microbiota analysis

High-intensity MedDiet

Experimental group

Description:

Patients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation

Treatment:

Other: Metabolome analysis

Other: Diet evaluation

Other: Immunological analysis

Other: MedDiet

Other: Proteome analysis

Other: Clinical evaluation

Other: Microbiota analysis