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NCT05456802Completed

Effect of Acute Cardiovascular Disease on Microbiome

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
60 (actual)
First submitted
30 Jun 2022
Start date
Aug 2022
Primary completion date
Feb 2024
Lead sponsor
University Hospital, Essen
NCT number
NCT05456802

What you commit to

  • Study type: Observational
  • Participants enrolled: 60
  • From Aug 2022 to the primary completion date, Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • active chemo or radiation therapy

Other illness

  • chronic inflammatory bowel disease
  • short bowel syndrome

Other

  • pregnancy/lactation period
  • current antibiotic treatment or in the past 3 months
  • artificial bowel outlet
  • persistent diarrhea or vomiting in the past 3 months
  • simultaneous participation in another interfering nutrition study

Who the study is looking for

  • \>18 years
  • patient consent
  • CCS, ACS or CLI
  • angiographical confirmed peripheral or coronary artery disease

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Essen, Clinic of Cardiology and Angiology
Coordinator of this site? Confirm its status
EssenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.