Microbiome, Inflammation and Genetics as a Target for Precision Medicine in AThERosclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Hospital General Universitario Gregorio Marañon
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Change from baseline in clinical evaluation at 12 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Javier Bermejo Thomas
MD PhD Cardiology Department HGUGM
Hospital General Universitario Gregorio Marañon
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in clinical evaluation at 12 months
Time Frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Cardiac events register including hemostasis and biochemical determinations
Change from baseline in fibrous cap thickness at 12 months
Time Frame: Inclusion and 12 months
Angiographic substudy-Change from baseline in the thickness of the fibrous cap (μm) of an atherosclerotic plaque in the nonculprit vessel as measured using optical coherence tomography
Secondary Outcomes
- Oral microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Endothelial dysfunction(Inclusion and 12 months)
- Intestinal microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Blood microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Intestinal microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Oral microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Adaptive immune system status changes(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Blood microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Innate immune system status changes(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)