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OpenTrials
Completed

NCT Number: NCT05456802

Effect of Acute Cardiovascular Disease on Microbiome

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.

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Key information

Conditions

Microbial Colonization Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Communicable Diseases Coronary Artery Disease Coronary Disease Critical Limb Ischemia Disease Attributes Heart Diseases Infarction Infections Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Essen, Clinic of Cardiology and Angiology

Essen, North Rhine-Westphalia, 45147, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care Treatment

Other

Standard of care treatment including percutaneous interventions was performed in all participants.

Primary outcomes

  1. Change of enteral microbiome composition after presentation with ACS/CCS/CLI

    Time frame: 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.

    Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.

  2. Change of oral microbiome composition after presentation with ACS/CCS/CLI

    Time frame: 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.

    Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.

Secondary outcomes

  1. Change of TMAO serum levels after presentation with ACS/CCS/CLI

    Time frame: Sampling 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).

  2. Change of SCFA serum levels after presentation with ACS/CCS/CLI

    Time frame: Sampling 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).

Other outcomes

  1. Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI

    Time frame: Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

    Echocardiographical strain analysis will be performed at the below mentioned time points.

  2. Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI

    Time frame: Sampling 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.

  3. Change of blood pressure after presentation with ACS/CCS/CLI

    Time frame: Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

    Blood pressure will be measured at the below mentioned time points.

  4. Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI

    Time frame: PWV measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

    PWV will be measured at the below mentioned time points.

  5. Change in nitrite metabolism after presentation of ACS/CCS/CLI

    Time frame: Nitrite metabolism will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

    Nitrite metabolism will be assed by chemiluminescence detection (CLD).

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Acronym: MIAMI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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