Acute Coronary Syndrome Clinical Trial
— MEDIMACSOfficial 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.
Verified date | September 2022 |
Source | Consorcio Centro de Investigación Biomédica en Red, M.P. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 100 |
Est. completion date | August 2, 2022 |
Est. primary completion date | August 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Consorcio Centro de Investigación Biomédica en Red, M.P. | 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 |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrous cap thickness change | 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 | Endothelial dysfunction | Vascular endothelial function measured using a Doppler pressure guidewire | 12 months | |
Secondary | Intestinal microbiota composition changes | 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 | |
Secondary | Oral microbiota composition changes | 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 | |
Secondary | Adaptive immune system status changes | 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 | |
Secondary | Innate immune system status changes | 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 | |
Secondary | Blood protein profiling changes | 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 | |
Secondary | Faecal protein profiling changes | 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 | |
Secondary | Urine metabolome profiling changes | 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 | |
Secondary | Blood metabolome profiling changes | 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 | |
Secondary | Faecal metabolome profiling changes | 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 |
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