The Microbiome as a Target for Precision Medicine in Atherosclerosis
NCT ID: NCT03434483
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
156 participants
OBSERVATIONAL
2018-02-25
2021-02-08
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Acute Coronary Syndrome
Patients with an episode of acute coronary syndrome. Clinical evaluation 1 year. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis.
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
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.
Immunological analysis
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Clinical evaluation
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
ACS-Angiographic substudy
Patients included in the Acute Coronary Syndrome group with clinical indication for revascularization.
Clinical evaluation. Assessment of the atherosclerotic plaque in a moderate lession at baseline and 1-year .
Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis
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.
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
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.
Immunological analysis
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Clinical evaluation
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
Chronic coronary atherosclerosis
Patients with chronic atherosclerosis. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis.
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
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.
Immunological analysis
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Clinical evaluation
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
Interventions
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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.
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
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.
Immunological analysis
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Clinical evaluation
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signature of informed consent for the study (Annex I).
* Clinical indication of coronary angiography in the acute phase (in the first 72 hours after its hospital diagnosis).
* At least one non-causal coronary lesion in a coronary segment with reference diameter\> 2 mm, stenosis between 40-80%, and TIMI 3 flow in this vessel (angiographic criteria, only confirmed after performing coronary angiography)
* Signature of informed consent for the substudy (Annex II).
* Angiographic diagnosis, using catheterization or computed tomography of coronary atherosclerotic disease.
* Clinical situation of stable chronic ischemic heart disease.
* Signature of informed consent for the study (Annex III).
Exclusion Criteria
* History of heart failure
* Systemic inflammatory diseases
* In treatment with corticosteroids or immunomodulators
* In treatment with antibiotics during the last month
* Renal insufficiency with creatinine clearance less than 30 ml / h
* Hepatic insufficiency: patients with cirrhosis in Child B or C stages will be excluded.
* Previous Ejection fraction of VI less than 30%.
* History of heart failure
* Systemic inflammatory diseases
* In treatment with corticosteroids or immunomodulators
* In treatment with antibiotics during the last month
18 Years
ALL
No
Sponsors
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Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Javier Bermejo Thomas
MD PhD Cardiology Department HGUGM
Principal Investigators
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Francisco Fernández-Aviles, Prof, MD
Role: STUDY_DIRECTOR
Hospital General Universitario Gregorio Marañón
Locations
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Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Countries
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References
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I Fernandez-Avila A, Gutierrez-Ibanes E, Martin de Miguel I, Sanz-Ruiz R, Gabaldon A, Fernandez-Aviles F, Gomez-Lara J, Fernandez-Castillo M, Vazquez-Cuesta S, Martinez-Legazpi P, Lozano-Garcia N, Blazquez-Lopez E, Yotti R, Lopez-Cade I, Reigadas E, Munoz P, Elizaga J, Correa R, Bermejo J. One-year longitudinal changes of peripheral CD4+ T-lymphocyte counts, gut microbiome, and plaque vulnerability after an acute coronary syndrome. Int J Cardiol Heart Vasc. 2024 Jun 4;53:101438. doi: 10.1016/j.ijcha.2024.101438. eCollection 2024 Aug.
Other Identifiers
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PIE 16/00055
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FIBHGM-MIGATER
Identifier Type: -
Identifier Source: org_study_id
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