The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Microbial Colonization
- Sponsor
- University Hospital, Essen
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change of enteral microbiome composition after presentation with ACS/CCS/CLI
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Chistos Rammos
Professor Dr. med.
University Hospital, Essen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change of enteral microbiome composition after presentation with ACS/CCS/CLI
Time Frame: 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.
Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Change of oral microbiome composition after presentation with ACS/CCS/CLI
Time Frame: 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.
Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Secondary Outcomes
- Change of TMAO serum levels after presentation with ACS/CCS/CLI(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(Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.)