Effect of Acute Cardiovascular Disease on Microbiome

Study Overview
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Brief Summary
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Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world. An interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome. Aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.

Official Title
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The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites

Conditions
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Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Arterial Disease, Critical Limb Ischemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years patient consent CCS, ACS or CLI angiographical confirmed peripheral or coronary artery disease Exclusion Criteria: pregnancy/lactation period current antibiotic treatment or in the past 3 months chronic inflammatory bowel disease short bowel syndrome artificial bowel outlet persistent diarrhea or vomiting in the past 3 months simultaneous participation in another interfering nutrition study active chemo or radiation therapy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Acute Coronary Syndrome (ACS)<br>Patients presenting to the clinic with acute coronary syndrome. This includes: ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) with confirmed diagnosis of coronary artery disease. | |
| Chronic Coronary Syndrome (CCS)<br>Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease. | |
| Critical limb ischemia (CLI)<br>Patients presenting to the clinic with critical limb ischemia. This includes: Resting limb pain (Fontaine III), ulcerations (Fontaine IV) and Ankle brachial index (ABI) < 0,6 and confirmed diagnosis of peripheral artery disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of enteral microbiome composition after presentation with ACS/CCS/CLI | Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis. | Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation. | 
| Change of oral microbiome composition after presentation with ACS/CCS/CLI | Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis. | Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of TMAO serum levels after presentation with ACS/CCS/CLI | Blood samples are collected at the below mentioned time points. TMAO serum levels will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). | Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. | 
| Change of SCFA serum levels after presentation with ACS/CCS/CLI | Blood samples are collected at the below mentioned time points. SCFA serum levels will be measured by high-performance liquid chromatography (HPLC). | Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. |