MIAMI: Effect of Acute Cardiovascular Disease on Microbiome

Sponsor

University Hospital, Essen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05456802

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization Coronary Artery Disease Myocardial Infarction Acute Coronary Syndrome Peripheral Arterial Disease Critical Limb Ischemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acute Coronary Syndrome (ACS) Patients presenting to the clinic with acute coronary syndrome. This includes: ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) with confirmed diagnosis of coronary artery disease.
Chronic Coronary Syndrome (CCS) Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease.
Critical limb ischemia (CLI) Patients presenting to the clinic with critical limb ischemia. This includes: Resting limb pain (Fontaine III), ulcerations (Fontaine IV) and Ankle brachial index (ABI) < 0,6 and confirmed diagnosis of peripheral artery disease.

Outcome Measures

Primary Outcome Measures

Change of enteral microbiome composition after presentation with ACS/CCS/CLI [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.
Change of oral microbiome composition after presentation with ACS/CCS/CLI [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 Outcome Measures

Change of TMAO serum levels after presentation with ACS/CCS/CLI [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).
Change of SCFA serum levels after presentation with ACS/CCS/CLI [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 Outcome Measures

Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI [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.
Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI [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.
Change of blood pressure after presentation with ACS/CCS/CLI [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.
Change of pulse wave velocity (PWV) after presentation with ACS/CCS/CLI [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.
Change in nitrite metabolism after presentation of ACS/CCS/CLI [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).