Effect of Acute Cardiovascular Disease on Microbiome
- Conditions
- Microbial ColonizationPeripheral Arterial DiseaseCoronary Artery DiseaseCritical Limb IschemiaMyocardial InfarctionAcute Coronary Syndrome
- Registration Number
- NCT05456802
- Lead Sponsor
- University Hospital, Essen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- >18 years
- patient consent
- CCS, ACS or CLI
- angiographical confirmed peripheral or coronary artery disease
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of enteral microbiome composition after presentation with ACS/CCS/CLI 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 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 Outcome Measures
Name Time Method 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. 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).
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. Blood samples are collected at the below mentioned time points. SCFA serum levels will be measured by high-performance liquid chromatography (HPLC).
Trial Locations
- Locations (1)
University of Essen, Clinic of Cardiology and Angiology
🇩🇪Essen, NRW, Germany
University of Essen, Clinic of Cardiology and Angiology🇩🇪Essen, NRW, Germany