The Microbiome as a Target for Precision Medicine in Atherosclerosis

NCT03434483 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2021-08-05

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434483 on ClinicalTrials.gov