Phase None Completed NCT05456802

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

University Hospital, Essen · Observational

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Completed April 2024. Read the results summary below →
Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT05456802).

Results summary

None

Outcome data

EndpointTypeResultSignificance
Change of enteral microbiome composition after presentation with ACS/CCS/CLI Primary None None
Change of oral microbiome composition after presentation with ACS/CCS/CLI Primary None None
Change of TMAO serum levels after presentation with ACS/CCS/CLI Secondary None None
Change of SCFA serum levels after presentation with ACS/CCS/CLI Secondary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase None
Study type
Observational
Enrollment (final)
60 participants
Started
August 2022
Actually completed
April 2024

Recruitment criteria

Age range: ≥ 18 · Sex: All · Healthy volunteers: Requires diagnosis

Locationsi

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

University of Essen, Clinic of Cardiology and Angiology — Essen, North Rhine-Westphalia (Germany)

Sources

REG
ClinicalTrials.gov — NCT05456802
Trial registry · primary record
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