Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome (MEDIMACS)
Acute Coronary Syndrome
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Atherosclerosis, Mediterranean diet, microbiota, immune system, metabolome, proteome
Eligibility Criteria
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
Sites / Locations
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Control
High-intensity MedDiet
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
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