The Microbiome as a Target for Precision Medicine in Atherosclerosis
NCT03434483 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156
Last updated 2021-08-05
Summary
Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.
Conditions
- Acute Coronary Syndrome
- Atherosclerosis
Interventions
- PROCEDURE
-
Assessment of the atherosclerotic plaque in a moderate lession.
In patients who have been successfully revascularized the artery responsible for AMI and also present an intermediate lesion (40-80%) in another coronary territory, the clinical care protocol of the Cardiology Service stipulates the need for a physiological assessment with guidance of pressure (FFR). The thickness of the fibrous cap shall be measured using optical coherence tomography. In addition to the FFR measurement, a complete physiological assessment with a Doppler-pressure guide. This will allow the procedure to be performed without additional risk to the patient. The physiological study will include the analysis of endothelium-dependent vascular function and endothelium-independent vascular function.
- GENETIC
-
Gene variants in atherosclerosis
From the blood samples of the patients, the total DNA will be extracted and the main functional variants identified in the literature will be genotyped
- OTHER
-
Microbiota analysis
From the samples of blood, feces, oral cavity and blood, 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.
- OTHER
-
Immunological analysis
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
- OTHER
-
Clinical evaluation
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
Sponsors & Collaborators
-
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
collaborator OTHER -
Hospital General Universitario Gregorio Marañon
lead OTHER
Principal Investigators
-
Francisco Fernández-Aviles, Prof, MD · Hospital General Universitario Gregorio Marañón
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-25
- Primary Completion
- 2021-02-08
- Completion
- 2021-02-08
Countries
- Spain
Study Locations
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