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Effect of Acute Cardiovascular Disease on Microbiome

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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of enteral microbiome composition after presentation with ACS/CCS/CLISampling 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/CLISampling 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
NameTimeMethod
Change of TMAO serum levels after presentation with ACS/CCS/CLISampling 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/CLISampling 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

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