The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.

Study Overview
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Brief Summary
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Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).

Detailed Description
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A total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-ST elevation myocardial infarction and 75 patients with ST- elevation myocardial infarction will be included. Clinical information, blood samples and fecal samples will be collected. Fecal and blood samples will be collected once in patients With chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.

Official Title
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The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.

Conditions
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Coronary Artery Disease, Intestinal Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary heart disease verified by coronary angiography Exclusion Criteria: Current infection requiring intravenous antibiotics Inflammatory bowel disease Renal failure with creatinine > 200µmol/L Hepatic impairment Pregnancy Previous bariatric surgery Colostomy Active malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic coronary syndrome<br>50 patients with chronic coronary disease | |
| Non ST segment-elevation myocardial infarction<br>75 patients with non ST-elevation myocardial infarction | |
| ST-elevation myocardial infarction<br>75 patients with ST segment-elevation myocardial infarction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota alpha diversity in myocardial infarction measured as Chao1 Index. | fecal-sample. 16srRNA (Miseq) will be used for sequencing. | Within 7 days from inclusion. | 
| Microbiota alpha diversity in myocardial infarction measured as Chao1 Index | fecal-sample. 16srRNA (Miseq) will be used for sequencing. | At 3 months follow-up. | 
| Lipopolysaccharide binding protein (LBP) in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | At inclusion | 
| Lipopolysaccharide binding protein (LBP) in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | Change from inclusion to 3 months follow-up. | 
| Soluble cluster of difference-14 in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | At inclusion | 
| Soluble cluster of difference-14 in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | Change from inclusion to 3 months follow-up. | 
| Intestinal fatty acid binding protein-1 in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | At inclusion | 
| Intestinal fatty acid binding protein-1 in myocardial infarction | Blood sample. Analyses will be performed with ELISA. | Change from inclusion to 3 months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut leakage, Microbiota, Coronary artery disease, STEMI, NSTEMI, Chronic coronary syndrome