Effect of Acute Cardiovascular Disease on Microbiome

Coronary Artery Disease Clinical Trial

— MIAMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456802
• Other study ID #: MIAMI Trial
• Status: Recruiting
• Start date: August 12, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Essen
• Contact: Christos Rammos, Prof. Dr.
• Phone: 0049201 723
• Email: christos.rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Limb-Threatening Ischemia
• Communicable Diseases
• Coronary Artery Disease
• Critical Limb Ischemia
• Infections
• Microbial Colonization
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Germany	University of Essen, Clinic of Cardiology and Angiology	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI	Echocardiographical strain analysis will be performed at the below mentioned time points.	Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Other	Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI	Blood samples are collected at the below mentioned time points.	Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Other	Change of blood pressure after presentation with ACS/CCS/CLI	Blood pressure will be measured at the below mentioned time points.	Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Other	Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI	PWV will be measured at the below mentioned time points.	PWV measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Other	Change in nitrite metabolism after presentation of ACS/CCS/CLI	Nitrite metabolism will be assed by chemiluminescence detection (CLD).	Nitrite metabolism will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Primary	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.
Primary	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	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.
Secondary	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.