Effect of Acute Cardiovascular Disease on Microbiome (MIAMI)

University Hospital Essen

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Critical Limb Ischemia; Microbial Colonization; Myocardial Infarction; Peripheral Arterial Disease

Treatments: Other: Standard of care treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05456802

MIAMI Trial

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Acute Coronary Syndrome (ACS)

Description:

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.

Treatment:

Other: Standard of care treatment

Chronic Coronary Syndrome (CCS)

Description:

Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease.

Treatment:

Other: Standard of care treatment

Critical limb ischemia (CLI)

Description:

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.

Treatment:

Other: Standard of care treatment