Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Fibrous cap thickness change
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed 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.
Investigators
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
Outcomes
Primary Outcomes
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
- Intestinal microbiota composition changes(12 months)
- Adaptive immune system status changes(12 months)
- Faecal metabolome profiling changes(12 months)
- Blood protein profiling changes(12 months)
- Innate immune system status changes(12 months)
- Faecal protein profiling changes(12 months)
- Blood metabolome profiling changes(12 months)
- Endothelial dysfunction(12 months)
- Oral microbiota composition changes(12 months)
- Urine metabolome profiling changes(12 months)