NCT03434483

The Microbiome as a Target for Precision Medicine in Atherosclerosis

Microbiome, Inflammation and Genetics as a Target for Precision Medicine in AThERosclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will prospectively study two groups of patients : 1) patients with acute coronary syndrome and 2) age and sex matched patients with chronic stable documented atherosclerosis. Immune cell populations and immune-related metabolites will be characterized, the genetic profile of the main known functional variants will be determined, and the oral, gastrointestinal, and blood microbiota will be compared in both groups in a transversal observational design. In addition, 1-year clinical follow-up will be performed and correlation with the evolution of the microbiota and immune response in a longitudinal design will be conducted. Besides, an angiographic substudy, for those patients included in the study but that require revascularization of culprit artery according to clinical indication, will be 1 year follow-up and functional assessment and intravascular imaging and the degree of remodelling of the atherosclerotic plaque will be correlated with the evolution of the microbiota and immune response in a longitudinal design.

Conditions

• Acute Coronary Syndrome
• Atherosclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-02-25
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2018-02-15
• Last updated: 2021-08-05

Locations

1 site across 1 country: Spain