Clinical trial NCT05456802: Effect of Acute Cardiovascular Disease on Microbiome
Official title: The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
Peripheral Arterial Disease
Critical Limb Ischemia
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years presenting to the clinic with acute coronary syndrome (ACS), chronic coronary syndrome (CCS) or critical limb threatening ischemia (CLI) who can be included into the study within a 24 hours time frame after presentation.

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.


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

Primary outcomes:
measure: Change of enteral microbiome composition after presentation with ACS/CCS/CLI
timeFrame: 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.
measure: Change of oral microbiome composition after presentation with ACS/CCS/CLI
timeFrame: 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 outcomes:
measure: Change of TMAO serum levels after presentation with ACS/CCS/CLI
timeFrame: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
measure: Change of SCFA serum levels after presentation with ACS/CCS/CLI
timeFrame: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Other outcomes:
measure: Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI
timeFrame: Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
measure: Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI
timeFrame: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
measure: Change of blood pressure after presentation with ACS/CCS/CLI
timeFrame: Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
measure: Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI
timeFrame: PWV measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
measure: Change in nitrite metabolism after presentation of ACS/CCS/CLI
timeFrame: Nitrite metabolism will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Locations:
city: Essen
country: Germany
facility: University of Essen, Clinic of Cardiology and Angiology
state: NRW
Study officials:
affiliation: University Clinic Essen
name: Christos Rammos, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: