Acute Coronary Syndrome, Coronary Artery Disease, Critical Limb Ischemia, Microbial Colonization, Myocardial Infarction, Peripheral Arterial Disease
Conditions
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.
Interventions
OTHERStandard of care treatment
Standard of care treatment including percutaneous interventions was performed in all participants.
Sponsors
University Hospital, Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI | Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. | Echocardiographical strain analysis will be performed at the below mentioned time points. |
| Change in nitrite metabolism after presentation of ACS/CCS/CLI | Nitrite metabolism will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. | Nitrite metabolism will be assed by chemiluminescence detection (CLD). |
| Change of inflammatory profile (CRP, PCT, Interleukin panel) 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. |
| Change of blood pressure after presentation with ACS/CCS/CLI | Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. | Blood pressure will be measured at the below mentioned time points. |
| Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI | PWV measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation. | PWV will be measured at the below mentioned time points. |
Countries
Germany
Outcome results
None listed