- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842319
Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome (MEDIMACS)
September 30, 2022 updated by: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Maranon
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
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
|
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.
A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
A study of host and microbiota proteome will be carried out from samples using mass spectrometry
A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods
Clinical evaluation including hemostasis and biochemical studies
Biochemical analysis and questionaries for diet adherence and exercise registration
|
Experimental: High-intensity MedDiet
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
|
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.
A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
A study of host and microbiota proteome will be carried out from samples using mass spectrometry
A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods
Clinical evaluation including hemostasis and biochemical studies
Biochemical analysis and questionaries for diet adherence and exercise registration
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial dysfunction
Time Frame: 12 months
|
Vascular endothelial function measured using a Doppler pressure guidewire
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Francisco Fernández-Avilés, Professor, CIBER, HGUGM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2019
Primary Completion (Actual)
August 2, 2022
Study Completion (Actual)
August 2, 2022
Study Registration Dates
First Submitted
February 13, 2019
First Submitted That Met QC Criteria
February 13, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBER-MEDIMACS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The Consortium Partners involved in data creation and analysis agrees to follow the FAIR data management principles of Findability, Accessibility, Interoperability and Reusability.
The Project Management Committee will decide what type and format of data to be stored in the collective database and what type and format of data will be available publicly (as an open-access to research data), as well as how data will be curated and preserved after the end of the project.
Sequences, genotypes and protein and immune profiles would be organized and indexed in metadata files following a unique code of assignment that will be submitted for releasing to public database repositories such as GenBank, Gene Expression Omnibus and ClinicalTrials.
The International Standards for Genomes and Metagenomes will be followed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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